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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014