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OpenTrials
Completed

NCT Number: NCT00214019

The Effect of Salmeterol on Eosinophil (EOS) Function

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.

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Key information

Conditions

Allergic Asthma

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salmeterol

Drug

salmeterol diskus 50 mcg twice per day

Other names: Seravent, Advair

Fluticasone

Drug

placebo diskus, fluticasone MDI 88 mcg twice per day

Other names: flovent, advair

Placebo

Drug

placebo diskus

Other names: no drug, comparator treatment

Primary outcomes

  1. Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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