drugset / Trial / NCT00441441

A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma

NCT00441441

Phase 3 Completed 351 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Timeline

Start
2007-02
Primary completion
2008-01
Completion
2008-01

Publications

  • Background Li JS, Qaqundah PY, Weinstein SF, LaForce CF, Ellsworth AV, Ortega HG, Ferro TJ. Fluticasone propionate/salmeterol combination in children with asthma: key cardiac and overall safety results. Clin Res Reg Affairs 2010;27(3):87-95.

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 100 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled

Indications