drugset / Trial / NCT00448435

Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma

NCT00448435

Phase 3 Completed 51 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2007-04
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 50 ug Inhaled
Comparator Salmeterol Other / unclassified 25 ug Inhaled

Indications