At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
In Brief
A Phase 4 clinical trial evaluating fluticasone propionate/salmeterol (FSC), montelukast (MON), and 5 other interventions for Asthma. Completed, enrolled 725 participants across 121 sites in 4 countries.
Detailed Summary
This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
Study Details
Timeline
Interventions
fluticasone propionate/salmeterol DISKUS combination
montelukast capsule
fluticasone propionate aqueous nasal spray
vehicle placebo nasal spray
ADVAIR DISKUS
placebo capsule
placebo DISKUS