Trials / Completed
CompletedNCT00448435
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 5 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GW815SF HFA MDI | salmeterol and fluticasone propionate combination |
| DRUG | salmeterol and fluticasone propionate | salmeterol + fluticasone propionate |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
- First posted
- 2007-03-16
- Last updated
- 2010-06-08
- Results posted
- 2009-08-11
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00448435. Inclusion in this directory is not an endorsement.