Study Of Patients With Allergic Rhinitis And Asthma

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: fluticasone propionate/salmeterol
* Drug: fluticasone propionate
* Drug: montelukast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluticasone propionate/salmeterol|nan|
|Drug: fluticasone propionate|nan|
|Drug: montelukast|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning Peak Expiratory Flow |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Allergic Rhinitis