Study comparing dual combination of product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.
Study identifier:D5980C00023
ClinicalTrials.gov identifier:NCT04078126
EudraCT identifier:2019-001801-26
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
35
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 10 Sept 2019
Primary Completion Date: 30 Dec 2020
Study Completion Date: 30 Dec 2020
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| 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) |
Contacts
Investigators
Principal Investigator
Bärbel Huber
2601
