Study Of Patients With Allergic Rhinitis And Asthma

Condition(s) targeted: Asthma; Allergic Rhinitis

Intervention: fluticasone propionate/salmeterol (Drug); fluticasone propionate (Drug); montelukast (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Morning Peak Expiratory Flow

Secondary outcome: Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

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.

Exclusion Criteria:

- Have a history of life-threatening asthma.

- Been hospitalized for asthma within the 6 months prior to the study.

- Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.

GSK Clinical Trials Call Center, Ozark, Alabama 36360, United States

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Starting date: August 2005
Ending date: July 2007
Last updated: April 4, 2008