The Effect of Salmeterol on Eosinophil (EOS) Function

Study Overview
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Brief Summary
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This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

Detailed Description
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An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Official Title
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The Effect of Salmeterol on Eosinophil (EOS) Function

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: salmeterol
* Drug: Fluticasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-55 years of age history of asthma symptoms for the previous 6 months Forced Expiratory Value (FEV1) >75% of predicted positive prick skin test to cat, house dust mite or ragweed Exclusion Criteria: history of life threatening asthma or anaphylaxis current smoker pregnant or breast-feeding evidence of an upper respiratory infection within 4 weeks of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Diskus<br>Placebo comparator | Drug: Placebo<br>* placebo diskus<br>* Other names: comparator treatment;|
| Experimental: Salmeterol Diskus 50 mcg twice per day<br>Salmeterol Diskus 50 mcg twice per day | Drug: salmeterol<br>* salmeterol diskus 50 mcg twice per day<br>* Other names: Advair;|
| Experimental: Placebo diskus, fluticasone<br>placebo diskus, fluticasone MDI 88 mcg twice per day | Drug: Fluticasone<br>* placebo diskus, fluticasone MDI 88 mcg twice per day<br>* Other names: advair;|
| Experimental: Salmeterol, Fluticasone<br>Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day | Drug: salmeterol<br>* salmeterol diskus 50 mcg twice per day<br>* Other names: Advair;Drug: Fluticasone<br>* placebo diskus, fluticasone MDI 88 mcg twice per day<br>* Other names: advair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge | Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge. | Eosinophils are measured 24 hours after the subject has an antigen challenge |