Study identifier:D5980C00023
ClinicalTrials.gov identifier:NCT04078126
EudraCT identifier:2019-001801-26
CTIS identifier:N/A
A Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow
Chronic obstructive pulmonary disease (COPD)
Phase 3
No
-
All
35
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2022 by AstraZeneca
AstraZeneca
-
Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.
This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function
Location
Location
Gauting, Germany, 82131
Location
Landsberg, Germany, 86899
Location
Hannover, Germany, D-30173
Location
Frankfurt/Main, Germany, 60389
Arms | Assigned Interventions |
---|---|
Experimental: Budesonide and formoterol fumarate (MDI BFF) Subject treated with MDI BFF followed by washout period | Combination Product: BFF Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler) |
Active Comparator: Symbicort Turbuhaler Subject treated with Symbicort followed by washout period | Combination Product: Symbicort Turbuhaler Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler) |
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