Study Of Patients With Allergic Rhinitis And Asthma

GlaxoSmithKline600 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Asthma

Interventions

fluticasone propionate/salmeterolDRUG

fluticasone propionateDRUG

montelukastDRUG

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Locations (80)

Outcomes

Primary Outcomes

Morning Peak Expiratory Flow

Secondary Outcomes

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

Data from ClinicalTrials.gov

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