Study identifier:D5892C00014
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
Chronic Obstructive Pulmonary Disease
Phase 4
No
budesonide/formoterol Turbuhaler 320/9µg, formoterol Turbuhaler 9µg
All
137
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
Location
Location
BERLIN, Germany
Location
ERFURT, Germany
Location
FULDA, Germany
Location
FURTH, Germany
Location
GEESTHACHT, Germany
Location
GROBHANSDORF, Germany
Location
LEIPZIG, Germany
Location
NEURUPPIN, Germany
Arms | Assigned Interventions |
---|---|
Experimental: Symbicort then Formoterol then Placebo Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
Experimental: Formoterol then Symbicort then Placebo Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
Placebo Comparator: Placebo then Formoterol then Symbicort Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily | Drug: budesonide/formoterol Turbuhaler 320/9µg Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms Drug: formoterol Turbuhaler 9µg Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily Other: Placebo Placebo, 1 inhalation twice daily |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Patients were recruited in 12 centers in Germany and 12 centers in Switzerland. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Among 137 enrolled patients, 26 patients were not randomised (14 due to violation of inclusion/exclusion criteria, 2 due to adverse events, 1 due to development of study-specific discontinuation criteria, 7 due to voluntary discontinuation, 1 due to lost to follow-up, and 1 due to other reason.) |
Description | |
---|---|
Symbicort then Formoterol then Placebo | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily |
Formoterol then Symbicort then Placebo | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily |
Placebo then Formoterol then Symbicort | Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 36 | 37 | 38 |
COMPLETED | 36 | 37 | 38 |
NOT COMPLETED | 0 | 0 | 0 |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 36 | 37 | 38 |
COMPLETED | 35 | 34 | 32 |
NOT COMPLETED | 1 | 3 | 6 |
Withdrawal by Subject | 1 | 0 | 0 |
Adverse Event | 0 | 1 | 1 |
Protocol Violation | 0 | 1 | 1 |
Study-specific discontinuation criteria | 0 | 1 | 4 |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 33 | 35 | 33 |
COMPLETED | 33 | 35 | 33 |
NOT COMPLETED | 0 | 0 | 0 |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 33 | 35 | 33 |
COMPLETED | 29 | 32 | 31 |
NOT COMPLETED | 4 | 3 | 2 |
Adverse Event | 1 | 1 | 0 |
Study specific discontinuation criteria | 3 | 2 | 2 |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 29 | 30 | 33 |
COMPLETED | 29 | 29 | 33 |
NOT COMPLETED | 0 | 1 | 0 |
Study specific discontinuation criteria | 0 | 1 | 0 |
Symbicort then Formoterol then Placebo | Formoterol then Symbicort then Placebo | Placebo then Formoterol then Symbicort | |
---|---|---|---|
STARTED | 29 | 29 | 33 |
COMPLETED | 29 | 29 | 33 |
NOT COMPLETED | 0 | 0 | 0 |
Description | |
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Entire Study Population | Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily |
Entire Study Population | |
---|---|
Number of Participants
[units: Participants] |
111 |
Age Continuous [units: Year] Mean ( Full Range ) |
63.7 (42 to 83) |
Gender, Male/Female [units: Participants] |
|
Female | 27 |
Male | 84 |
Measure Type | Primary |
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Measure Name | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 hour post-dose |
Measure Description | Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods. |
Time Frame | Single measurement taken1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 98 | 99 |
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 hour post-dose [units: Seconds] Mean (Standard Deviation) |
529 (377) | 441 (292) | 406 (306) |
Measure Type | Secondary |
---|---|
Measure Name | Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose |
Measure Description | Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods. |
Time Frame | Single measurement taken 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 98 | 98 |
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose [units: Seconds] Mean (Standard Deviation) |
463 (312) | 408 (283) | 388 (306) |
Measure Type | Secondary |
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Measure Name | Forced Expiratory Flow (FEV1) Pre-dose |
Measure Description | The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment. |
Time Frame | Pre-dose at the start of treatment and pre-dose after one week of treatment |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 101 |
Forced Expiratory Flow (FEV1) Pre-dose [units: Liters] Mean (Standard Deviation) |
0.0830 (0.2480) | 0.0630 (0.2500) | -0.046 (0.1830) |
Measure Type | Secondary |
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Measure Name | Forced Vital Capacity (FVC) Pre-dose |
Measure Description | The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment. |
Time Frame | Pre-dose at the start of treatment and pre-dose after one week of treatment |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 101 |
Forced Vital Capacity (FVC) Pre-dose [units: Liters] Mean (Standard Deviation) |
0.060 (0.406) | 0.067 (0.407) | -0.094 (0.360) |
Measure Type | Secondary |
---|---|
Measure Name | Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) |
Measure Description | The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment. |
Time Frame | Pre-dose at the start of treatment and pre-dose after one week of treatment |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 101 |
Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment) [units: Liters] Mean (Standard Deviation) |
0.105 (0.3600) | 0.089 (0.370) | -0.083 (0.371) |
Measure Type | Secondary |
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Measure Name | Peak Expiratory Flow (PEF) Before Morning Dose |
Measure Description | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period. |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
97 | 98 | 100 |
Peak Expiratory Flow (PEF) Before Morning Dose [units: Liters/minute] Mean (Standard Deviation) |
1.30 (32.70) | 5.60 (21.50) | -10.00 (27.00) |
Measure Type | Secondary |
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Measure Name | Sleep Score |
Measure Description | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms). |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
98 | 99 | 101 |
Sleep Score [units: Score on Scale] Mean (Standard Deviation) |
-1.70 (0.47) | -0.03 (0.47) | 0.11 (0.47) |
Measure Type | Secondary |
---|---|
Measure Name | Breathlessness Score |
Measure Description | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included. |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
98 | 99 | 101 |
Breathlessness Score [units: Score on Scale] Mean (Standard Deviation) |
-0.12 (0.54) | -0.40 (0.46) | 0.15 (0.49) |
Measure Type | Secondary |
---|---|
Measure Name | Chest Tightness Score |
Measure Description | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort). |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
98 | 99 | 101 |
Chest Tightness Score [units: Score on a scale] Mean (Standard Deviation) |
-0.08 (0.46) | -0.02 (0.47) | 0.17 (0.47) |
Measure Type | Secondary |
---|---|
Measure Name | Cough Score |
Measure Description | The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough). |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
98 | 99 | 101 |
Cough Score [units: Scores on a scale] Mean (Standard Deviation) |
-0.11 (0.51) | -0.05 (0.50) | 0.10 (0.45) |
Measure Type | Secondary |
---|---|
Measure Name | Number of Inhalations of Reliever Medication |
Measure Description | The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period. |
Time Frame | Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
97 | 99 | 101 |
Number of Inhalations of Reliever Medication [units: Number of inhalations during 24 hours] Mean (Standard Deviation) |
-0.42 (1.51) | -0.36 (1.26) | 0.51 (1.33) |
Measure Type | Secondary |
---|---|
Measure Name | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose |
Measure Description | The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness). |
Time Frame | Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 98 | 98 |
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose [units: Scores on a scale] Mean (Standard Deviation) |
3.3 (3.2) | 3.4 (3.1) | 3.9 (3.5) |
Measure Type | Secondary |
---|---|
Measure Name | Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose |
Measure Description | The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). |
Time Frame | Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 98 | 97 |
Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose [units: Scores on a scale] Mean (Standard Deviation) |
11.5 (2.7) | 11.6 (2.9) | 11.4 (2.9) |
Measure Type | Secondary |
---|---|
Measure Name | Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose |
Measure Description | The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). |
Time Frame | Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 98 | 98 |
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose [units: Scores on a scale] Mean (Standard Deviation) |
3.6 (3.2) | 3.4 (3.1) | 3.9 (3.5) |
Measure Type | Secondary |
---|---|
Measure Name | Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose |
Measure Description | The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included. |
Time Frame | Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
94 | 98 | 96 |
Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose [units: Scores on a scale] Mean (Standard Deviation) |
11.5 (2.9) | 11.5 (3.1) | 11.8 (3.1) |
Measure Type | Secondary |
---|---|
Measure Name | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
72 | 78 | 70 |
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose [units: Liter] Mean (Standard Deviation) |
2.06 (0.85) | 2.10 (0.82) | 1.97 (0.72) |
Measure Type | Secondary |
---|---|
Measure Name | Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
71 | 78 | 76 |
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose [units: Liters] Mean (Standard Deviation) |
2.12 (0.79) | 2.12 (0.80) | 1.85 (0.84) |
Measure Type | Secondary |
---|---|
Measure Name | Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 99 | 102 |
Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
2.75 (0.72) | 2.73 (0.77) | 2.37 (0.66) |
Measure Type | Secondary |
---|---|
Measure Name | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 99 | 102 |
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
2.19 (0.61) | 2.18 (0.70) | 1.91 (0.58) |
Measure Type | Secondary |
---|---|
Measure Name | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 99 | 102 |
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) [units: Liters] Median (Standard Deviation) |
5.59 (1.69) | 5.66 (1.61) | 5.79 (1.64) |
Measure Type | Secondary |
---|---|
Measure Name | Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 102 |
Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
4.83 (1.59) | 4.94 (1.62) | 5.13 (1.65) |
Measure Type | Secondary |
---|---|
Measure Name | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 99 | 102 |
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET) [units: Liter] Mean (Standard Deviation) |
7.58 (1.71) | 7.62 (1.68) | 7.45 (1.76) |
Measure Type | Secondary |
---|---|
Measure Name | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
96 | 99 | 101 |
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET) [units: kilopascal] Mean (Standard Deviation) |
2.90 (1.66) | 2.98 (1.81) | 4.22 (2.29) |
Measure Type | Secondary |
---|---|
Measure Name | Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 100 |
Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
2.69 (0.730) | 2.64 (0.78) | 2.42 (0.71) |
Measure Type | Secondary |
---|---|
Measure Name | Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 100 |
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
2.14 (0.60) | 2.08 (0.69) | 1.92 (0.66) |
Measure Type | Secondary |
---|---|
Measure Name | Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
94 | 99 | 99 |
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
5.47 (1.65) | 5.49 (1.45) | 5.82 (1.88) |
Measure Type | Secondary |
---|---|
Measure Name | Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
94 | 99 | 99 |
Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
4.74 (1.63) | 4.79 (1.52) | 5.19 (1.92) |
Measure Type | Secondary |
---|---|
Measure Name | Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
94 | 99 | 100 |
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET) [units: Liters] Mean (Standard Deviation) |
7.41 (1.68) | 7.37 (1.55) | 7.63 (2.00) |
Measure Type | Secondary |
---|---|
Measure Name | Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET |
Measure Description | Treatment means from individual participant data. |
Time Frame | Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
95 | 99 | 100 |
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET [units: Kilopascals] Mean (Standard Deviation) |
3.06 (1.68) | 3.20 (2.02) | 4.12 (2.54) |
Measure Type | Secondary |
---|---|
Measure Name | SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score |
Measure Description | Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data. |
Time Frame | Single measurement taken at the end of each 1-week treatment period |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |
---|---|---|---|
Number of
Participants Analyzed [units:participants] |
85 | 93 | 91 |
SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score [units: Scores on a scale] Mean (Standard Deviation) |
51.7 (18) | 51.6 (19.2) | 54.5 (18.9) |
Time Frame | No text entered. |
---|---|
Additional Description | No text entered. |
Description | |
---|---|
Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Total, serious adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 2/101 (1.98%) | 1/102 (0.98%) | 1/104 (0.96%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Injury, poisoning and procedural complications | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Wrist Fracture1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 1/101 (0.99%) | 0/102 (0.00%) | 0/104 (0.00%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Chronic Obstructive Pulmonary Disease1, † | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 1/101 (0.99%) | 1/102 (0.98%) | 1/104 (0.96%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Time Frame | No text entered. |
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Additional Description | No text entered. |
Threshold above which other adverse events are reported | 5% |
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Description | |
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Symbicort | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Formoterol | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily |
Placebo | Placebo, 1 inhalation twice daily |
Symbicort | Formoterol | Placebo | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 4/101 (3.96%) | 3/102 (2.94%) | 6/104 (5.77%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Respiratory, thoracic and mediastinal disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Chonic Obstructive Pulmonary Disease1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
# participants affected / at risk | 4/101 (3.96%) | 3/102 (2.94%) | 6/104 (5.77%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |
Name/Title: | Gerard Lynch |
Organization: | AstraZeneca |
E-mail: | [email protected] |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.