Trials / Completed
CompletedNCT00476073
Efficacy and Safety of Flutiform® pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (actual)
- Sponsor
- Mundipharma Research Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open, parallel group design. The study has a screening phase and a 12 week treatment phase. Subjects will be randomised to treatment in a 1:1 ration.
Detailed description
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive FLUTIFORM® or Sertetide®. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FLUTIFORM® (Formoterol fumarate / Fluticasone propionate) |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2007-05-21
- Last updated
- 2018-10-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00476073. Inclusion in this directory is not an endorsement.