The study will evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen - Allergen

Study identifier:D2340C00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A double-blind, double-dummy, randomised, placebo-controlled, 4-way, crossover, multi-centre Phase II study with budesonide as an active control to evaluate the efficacy and safety of 2 doses of inhaled AZD5423 over 7 days in patients with mild allergic asthma challenged with an inhaled allergen

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

AZD5423, Budesonide 200 microgram, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Dec 2011

Study Completion Date: 01 Dec 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

CALGARY, AB, Canada

Location

Research Site

HAMILTON, ON, Canada

Location

Research Site

QUEBEC, QC, Canada

Location

Research Site

SASKATOON, SK, Canada

Arms	Assigned Interventions
Experimental: 1 AZD5423 75ug	Drug: AZD5423 Suspension for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days
Experimental: 2 AZD5423 300ug	Drug: AZD5423 Suspension for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days
Active Comparator: 3 Budesonide 200 microgram	Drug: Budesonide 200 microgram Dry powder for inhalation twice daily 7 days Other Name: Pulmicort Drug: Placebo Solution for nebulisation once daily 7 days
Placebo Comparator: 4 Placebo	Drug: Placebo Solution for nebulisation once daily 7 days Drug: Placebo Solution for nebulisation once daily 7 days

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from 4 centres in the AllerGen CIC group in Canada.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total 27 patients enrolled, 20 (74.1%) patients were randomised to receive a treatment sequence consisting of 4 different treatment in random order. From 20 randomised patients, 18 (90%) patients completed the study and 2 (10%) patients were withdrawn from the study due to consumption of disallowed medication

Reporting Groups

	Description
ACBP	AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
APBC	AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
BACP	AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
BPCA	AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
CAPB	Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
CBAP	Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
CBPA	Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
PBAC	Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
PCAB	Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
PCBA	Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg

Participant Flow for 7 periods

Period 1: Period 1 - First treatment period

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	4	3	1	1	1	3	1	4	1
COMPLETED	1	4	3	1	1	1	3	1	4	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Period 2: Period 2 - Washout

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	4	3	1	1	1	3	1	4	1
COMPLETED	1	4	3	1	1	1	3	1	4	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Period 3: Period 3 - Second treatment period

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	4	3	1	1	1	3	1	4	1
COMPLETED	1	4	3	1	1	1	3	1	4	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Period 4: Period 4 - Washout

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	4	3	1	1	1	3	1	4	1
COMPLETED	1	3	3	1	1	1	3	1	4	1
NOT COMPLETED	0	1	0	0	0	0	0	0	0	0
Disallowed medication	0	1	0	0	0	0	0	0	0	0

Period 5: Period 5 - Third treatment period

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	3	3	1	1	1	3	1	4	1
COMPLETED	1	3	3	1	1	1	3	1	4	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0

Period 6: Period 6 - Washout

	ACBP	APBC	BACP	BPCA	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	3	3	1	1	1	3	1	4	1
COMPLETED	1	3	3	0	1	1	3	1	4	1
NOT COMPLETED	0	0	0	1	0	0	0	0	0	0
Disallowed medication	0	0	0	1	0	0	0	0	0	0

Period 7: Period 7 - Fourth treatment period

	ACBP	APBC	BACP	CAPB	CBAP	CBPA	PBAC	PCAB	PCBA
STARTED	1	3	3	1	1	3	1	4	1
COMPLETED	1	3	3	1	1	3	1	4	1
NOT COMPLETED	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Baseline Total	Total number of patients randomised and treated in the study

Baseline Measures

	Baseline Total
Number of Participants [units: Participants]	20
Age Continuous [units: Years] Mean ( Full Range )	29.6 (18 to 60)
Gender, Male/Female [units: Participants]
Female	9
Male	11
Race, Customized [units: Participants]
White	19
Others	1

Outcome Measures

1. Primary Outcome Measure: Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge compared to pre allergen challenge FEV1 [ Time Frame: From Randomization to end of treatment ]

Measure Type	Primary
Measure Name	Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge compared to pre allergen challenge FEV1
Measure Description	LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
Time Frame	From Randomization to end of treatment
Safety Issue?	No

Population Description

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.
PD Analysis set

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	19	19	19	19
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge compared to pre allergen challenge FEV1 [units: Percentage] Geometric Mean (Full Range)	90.97 (73.20 to 100.00)	91.32 (76.80 to 101.60)	87.28 (56.60 to 103.20)	85.83 (69.60 to 102.80)

No statistical analysis provided for Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge compared to pre allergen challenge FEV1

2. Secondary Outcome Measure: Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge [ Time Frame: From Randomization to end of treatment ]

Measure Type	Secondary
Measure Name	Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge
Measure Description	Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1
Time Frame	From Randomization to end of treatment
Safety Issue?	No

Population Description

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.
PD Analysis set

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	19	19	19	19
Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge [units: Percentage] Geometric Mean (Full Range)	69.75 (41.00 to 94.00)	69.57 (41.80 to 92.60)	67.98 (41.60 to 92.40)	69.30 (35.20 to 92.60)

No statistical analysis provided for Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge

3. Secondary Outcome Measure: Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge [ Time Frame: From Randomization to end of treatment ]

Measure Type	Secondary
Measure Name	Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge
Measure Description	AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1
Time Frame	From Randomization to end of treatment
Safety Issue?	No

Population Description

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.
PD Analysis set

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	19	19	19	19
Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge [units: Percentage] Geometric Mean (Full Range)
AUC over 0-3 (Average EAR)	83.82 (64.10 to 95.25)	83.71 (65.70 to 96.68)	81.90 (56.50 to 93.90)	82.26 (57.10 to 97.97)
AUC over 3-7 (Average LAR)	96.30 (87.62 to 104.67)	96.53 (85.70 to 103.93)	93.39 (69.69 to 107.34)	92.50 (80.77 to 106.23)

No statistical analysis provided for Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge

4. Secondary Outcome Measure: Airway hyperresponsiveness by assessment of methacholine PC20 [ Time Frame: Day 1 (pre-dose) ]

Measure Type	Secondary
Measure Name	Airway hyperresponsiveness by assessment of methacholine PC20
Measure Description	The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Time Frame	Day 1 (pre-dose)
Safety Issue?	No

Population Description

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.
PD Analysis set

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	19	19	19	20
Airway hyperresponsiveness by assessment of methacholine PC20 [units: mg/mL] Geometric Mean (Full Range)	1.560 (0.11 to 32.00)	1.651 (0.14 to 36.80)	1.688 (0.08 to 17.75)	1.538 (0.07 to 53.70)

No statistical analysis provided for Airway hyperresponsiveness by assessment of methacholine PC20

5. Secondary Outcome Measure: Airway Hyperresponsiveness by Assessment of Methacholine PC20 [ Time Frame: Day 5 ([post-dose] pre allergen challenge) ]

Measure Type	Secondary
Measure Name	Airway Hyperresponsiveness by Assessment of Methacholine PC20
Measure Description	The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Time Frame	Day 5 ([post-dose] pre allergen challenge)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	19	19	19	20
Airway Hyperresponsiveness by Assessment of Methacholine PC20 [units: mg/mL] Geometric Mean (Full Range)	1.755 (0.13 to 32.00)	2.693 (0.26 to 64.00)	2.477 (0.19 to 18.70)	2.034 (0.09 to 53.80)

No statistical analysis provided for Airway Hyperresponsiveness by Assessment of Methacholine PC20

6. Secondary Outcome Measure: Airway Hyperresponsiveness by Assessment of Methacholine PC20 [ Time Frame: Day 7 ([post-dose] 24 hours post allergen challenge) ]

Measure Type	Secondary
Measure Name	Airway Hyperresponsiveness by Assessment of Methacholine PC20
Measure Description	The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)
Time Frame	Day 7 ([post-dose] 24 hours post allergen challenge)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	17	19	19	18
Airway Hyperresponsiveness by Assessment of Methacholine PC20 [units: mg/mL] Geometric Mean (Full Range)	2.017 (0.21 to 32.00)	2.007 (0.15 to 45.89)	1.666 (0.06 to 17.19)	1.214 (0.06 to 35.10)

No statistical analysis provided for Airway Hyperresponsiveness by Assessment of Methacholine PC20

7. Secondary Outcome Measure: Changes in Sputum Eosinophils Differentials (Percentage) [ Time Frame: Day 5 (post dose) ]

Measure Type	Secondary
Measure Name	Changes in Sputum Eosinophils Differentials (Percentage)
Measure Description	The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Time Frame	Day 5 (post dose)
Safety Issue?	No

Population Description

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.
PD Analysis set

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	16	15	15	16
Changes in Sputum Eosinophils Differentials (Percentage) [units: Percentage] Mean (Standard Deviation)	1.891 (8.375)	-3.2 (9.162)	-1.825 (4.342)	-0.016 (1.835)

No statistical analysis provided for Changes in Sputum Eosinophils Differentials (Percentage)

8. Secondary Outcome Measure: Changes in Sputum Eosinophils Differentials (Percentage) [ Time Frame: Day 6 ([post dose] 7 hours post allergen challenge) ]

Measure Type	Secondary
Measure Name	Changes in Sputum Eosinophils Differentials (Percentage)
Measure Description	The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Time Frame	Day 6 ([post dose] 7 hours post allergen challenge)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	15	15	14	15
Changes in Sputum Eosinophils Differentials (Percentage) [units: Percentage] Mean (Standard Deviation)	0.633 (6.011)	0.592 (9.658)	7.500 (11.800)	12.333 (14.260)

No statistical analysis provided for Changes in Sputum Eosinophils Differentials (Percentage)

9. Secondary Outcome Measure: Changes in Sputum Eosinophils Differentials (Percentage) [ Time Frame: Day 7 ([post dose] 24 hours post allergen challenge) ]

Measure Type	Secondary
Measure Name	Changes in Sputum Eosinophils Differentials (Percentage)
Measure Description	The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)
Time Frame	Day 7 ([post dose] 24 hours post allergen challenge)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Measured Values

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Number of Participants Analyzed [units:participants]	16	14	15	14
Changes in Sputum Eosinophils Differentials (Percentage) [units: Percentage] Mean (Standard Deviation)	0.688 (8.230)	2.286 (15.417)	6.967 (11.697)	5.634 (5.520)

No statistical analysis provided for Changes in Sputum Eosinophils Differentials (Percentage)

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Serious Adverse Events

	Arm 1 - 75ug AZD5423	Arm 2 - 300ug AZD5423	Arm 3 - 2x200ug budesonide	Arm 4 - Placebo
Total, serious adverse events
# participants affected / at risk	0/19 (0.00%)	0/19 (0.00%)	0/19 (0.00%)	0/20 (0.00%)

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Arm 1 - 75ug AZD5423	75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 2 - 300ug AZD5423	300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
Arm 3 - 2x200ug budesonide	2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
Arm 4 - Placebo	Placebo administered in any of the first, second, third or fourth period of a particular sequence.

Other Adverse Events

Arm 1 - 75ug AZD5423

Arm 2 - 300ug AZD5423

Arm 3 - 2x200ug budesonide

Arm 4 - Placebo

Total, other (not including serious) adverse events

# participants affected / at risk

8/19 (42.11%)

1/19 (5.26%)

9/19 (47.37%)

9/20 (45.00%)

Eye disorders

CONJUNCTIVITIS^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Gastrointestinal disorders

ABDOMINAL DISCOMFORT^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Gastrointestinal disorders

ABDOMINAL PAIN UPPER^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

Gastrointestinal disorders

DRY MOUTH^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Gastrointestinal disorders

DYSPHAGIA^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Gastrointestinal disorders

GASTROOESOPHAGEAL REFLUX DISEASE^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

General disorders and administration site conditions

PYREXIA^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Infections and infestations

BRONCHITIS^†

# participants affected / at risk

0/19 (0.00%)

2/19 (10.53%)

0/20 (0.00%)

Infections and infestations

NASOPHARYNGITIS^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Infections and infestations

PHARYNGITIS BACTERIAL^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Infections and infestations

UPPER RESPIRATORY TRACT INFECTION^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Infections and infestations

VIRAL PHARYNGITIS^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Infections and infestations

VIRAL UPPER RESPIRATORY TRACT INFECTION^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Injury, poisoning and procedural complications

CONTUSION^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Injury, poisoning and procedural complications

SCRATCH^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

Investigations

HELICOBACTER TEST POSITIVE^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

Musculoskeletal and connective tissue disorders

MUSCULOSKELETAL CHEST PAIN^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Nervous system disorders

HEADACHE^†

# participants affected / at risk

2/19 (10.53%)

0/19 (0.00%)

1/19 (5.26%)

1/20 (5.00%)

Psychiatric disorders

INSOMNIA^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Reproductive system and breast disorders

DYSMENORRHOEA^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

Respiratory, thoracic and mediastinal disorders

ASTHMA^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Respiratory, thoracic and mediastinal disorders

DYSPHONIA^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Respiratory, thoracic and mediastinal disorders

DYSPNOEA^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

Respiratory, thoracic and mediastinal disorders

NASAL CONGESTION^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

2/20 (10.00%)

Respiratory, thoracic and mediastinal disorders

OROPHARYNGEAL PAIN^†

# participants affected / at risk

2/19 (10.53%)

0/19 (0.00%)

1/19 (5.26%)

2/20 (10.00%)

Skin and subcutaneous tissue disorders

DRUG ERUPTION^†

# participants affected / at risk

0/19 (0.00%)

1/19 (5.26%)

0/20 (0.00%)

Skin and subcutaneous tissue disorders

ERYTHEMA^†

# participants affected / at risk

1/19 (5.26%)

0/19 (0.00%)

0/20 (0.00%)

Skin and subcutaneous tissue disorders

URTICARIA^†

# participants affected / at risk

0/19 (0.00%)

1/20 (5.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary,

Certain Agreements

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:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: PI shall not publish any results until (i) the date of the first Study results publication, or in case of a Multi-Centre Study the first Multi-Centre Results publication, agreed by the participating sites, and (ii) the end of the eighteen (18) month period following the completion or early termination of the Study at all participating sites.

Limitations and Caveats

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
Of the 27 patients enrolled, 20 (74.1%) patient were randomised to receive a treatment sequence consisting of 4 different treatment in random order. 19 patients completed each individual treatment period and 17 patients completed all 4 treatment

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Christer Hultquist

AstraZeneca R&D Mölndal, Sweden

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

CSR Synopsis

Trial Results Summaries