Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma
NCT01099722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261
Last updated 2018-10-24
Summary
A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.
Conditions
Interventions
- DRUG
-
Flutiform
inhaler 2 puffs bd daily
- DRUG
-
Symbicort Turbohaler
2 puffs bd daily
Sponsors & Collaborators
-
Mundipharma Research Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2010-11-30
- Completion
- 2011-07-31
Countries
- Bulgaria
- Hungary
- India
- Poland
- Romania
Study Locations
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