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

GlaxoSmithKline1 site in 1 country600 target enrollmentSeptember 2005

ConditionsAsthma

Drugsfluticasone propionate/salmeterol fluticasone propionate montelukast

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 600
Locations: 1
Primary Endpoint: Morning Peak Expiratory Flow
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

July 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have asthma for at least 3 months prior to the study.
•Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
•Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
•Have a positive allergy skin test.