Study Of Patients With Allergic Rhinitis And Asthma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: montelukast; Drug: fluticasone propionate/salmeterol; Drug: fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00296530

ADA103578

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind