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Formoterol Fumarate Pressair vs Foradil in Asthma
NCT01641081Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2012
- Primary completion
- Feb 2013
- Countries
- 1
- Sponsor
- AstraZeneca
- Modality
- Small Molecules
- Drugs
- formoterol
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of formoterol in asthma (5 arms), sponsored by AstraZeneca. Primary endpoint: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose at Day 14. Started Jun 2012; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Experimental 1
Formoterol Fumarate in the Pressair DPI, Low Dose
Experimental 2
Formoterol Fumarate in the Pressair DPI, High Dose
Active Comparator 1
Foradil Aerolizer, Low Dose
Active Comparator 2
Foradil Aerolizer, High Dose
Placebo
Dose matched placebo
03
Who it enrols
Patients with mild-to-moderate asthma for at least 6 months, on stable ICS for 30 days, with FEV1 60-85% predicted and demonstrated reversibility.
04
Endpoints
Primary
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose
Secondary
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose
05
Results
Primary endpoints met
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