The Effect of Salmeterol on Eosinophil (EOS) Function

Not Applicable

Completed

• Conditions: Allergic Asthma
• Interventions: Drug: Placebo; Drug: salmeterol; Drug: Fluticasone

• Registration Number: NCT00214019
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2016-06-24
• Results First Posted: 2016-08-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Diskus	Placebo	Placebo comparator
Salmeterol Diskus 50 mcg twice per day	salmeterol	Salmeterol Diskus 50 mcg twice per day
Placebo diskus, fluticasone	Fluticasone	placebo diskus, fluticasone MDI 88 mcg twice per day
Salmeterol, Fluticasone	Fluticasone	Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
Salmeterol, Fluticasone	salmeterol	Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day

Primary Outcome Measures

Name	Time	Method
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge	Eosinophils are measured 24 hours after the subject has an 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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States