The Effect of Salmeterol on Eosinophil (EOS) Function

October 17, 2017 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Diskus
Placebo comparator
Drug: Placebo
placebo diskus
Other Names:
  • no drug
  • comparator treatment
Experimental: Salmeterol Diskus 50 mcg twice per day
Drug: salmeterol
salmeterol diskus 50 mcg twice per day
Other Names:
  • Advair
  • Seravent
Experimental: Placebo diskus, fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
Drug: Fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
Other Names:
  • flovent
  • advair
Experimental: Salmeterol, Fluticasone
Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
Drug: salmeterol
salmeterol diskus 50 mcg twice per day
Other Names:
  • Advair
  • Seravent
Drug: Fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
Other Names:
  • flovent
  • advair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Eosinophils are measured 24 hours after the subject has an antigen challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2003-0469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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