drugset / Trial / NCT00156819

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

NCT00156819

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.

Timeline

Start
2003-06
Primary completion
2005-08
Completion
2006-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Other / unclassified 100 ug Inhaled
Subject Montelukast Other / unclassified 5 mg
Subject Montelukast Other / unclassified 10 mg
Subject Salmeterol Other / unclassified 50 ug

Indications