Study Of RV-39 In Patients Who Also Have Asthma

Study Overview
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Brief Summary
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This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. 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
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An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus

Conditions
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Asthma

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


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. Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor. Have a positive allergic status antibody test. Exclusion Criteria: Have a history of life-threatening asthma. Been hospitalized for asthma within the 24 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: 18 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: fluticasone propionate/salmeterol<br>* comparator<br>* Other names: fluticasone propionate;|
| Active Comparator: Arm 2<br> | Drug: fluticasone propionate<br>* Comparator<br>|
| Placebo Comparator: Arm 3<br> | Drug: placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 | The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 | PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 | 
| Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4 | FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 | 
| Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4 | eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed. | Days 1 through 4 | 

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