Trials / Completed
CompletedNCT00475813
Study of FLUTIFORM® VS Seretide® in Paediatric Subjects With Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Mundipharma Research Limited · Industry
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
Study compares the efficacy and safety of FLUTIFORM® with Seretide® in the treatment of mild to moderate persistent asthma in pediatric subjects.
Detailed description
This is a study involving a 12 week treatment phase followed by a 6 month extension phase. During the treatment phase subjects receive FLUTIFORM® or Seretide®. In the extension phase all subjects receive FLUTIFORM®. 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
- 2007-03-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-05-21
- Last updated
- 2018-10-24
Locations
6 sites across 6 countries: Czechia, France, Germany, Hungary, Poland, Romania
Source: ClinicalTrials.gov record NCT00475813. Inclusion in this directory is not an endorsement.