Official Title: “See Detailed Description”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

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

Intervention(s) in this Clinical Trial

• Drug: fluticasone propionate/salmeterol
• Drug: fluticasone propionate
• Drug: montelukast

Primary Measures

• Morning Peak Expiratory Flow

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296530

Study ID Number: ADA103578

ClinicalTrials.gov Identifier: NCT00296530

Health Authority: United States: Food and Drug Administration