The Effect of Salmeterol on Eosinophil Function

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214019
First received: September 13, 2005
Last updated: October 31, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention
Mild Allergic Asthma
Drug: salmeterol, fluticasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effect of Salmeterol on Eosinophil Function

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • sputum eosinophils post antigen challenge

Secondary Outcome Measures:
  • sputum eos pre antigen challenge, blood eos pre and post antigen challenge, methacholine PC20 post antigen challenge

Estimated Enrollment: 16
Study Start Date: November 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-55 years of age
  • history of asthma symptoms for the previous 6 months
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214019

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
GlaxoSmithKline
Investigators
Principal Investigator: William Busse, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Board of Regents of the Universtiy of Wisconsin System, University of Wisconsin- Madison
ClinicalTrials.gov Identifier: NCT00214019     History of Changes
Other Study ID Numbers: H-2003-0469
Study First Received: September 13, 2005
Last Updated: October 31, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014