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The Effect of Salmeterol on Eosinophil (EOS) Function

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214019
First received: September 13, 2005
Last updated: June 24, 2016
Last verified: June 2016
  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
Allergic Asthma
Drug: salmeterol
Drug: Fluticasone
Drug: Placebo

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge [ Time Frame: Eosinophils are measured 24 hours after the subject has an antigen challenge ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: November 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Diskus
Placebo comparator
Drug: Placebo
placebo diskus
Other Names:
  • no drug
  • comparator treatment
Experimental: Salmeterol Diskus 50 mcg twice per day
Salmeterol Diskus 50 mcg twice per day
Drug: salmeterol
salmeterol diskus 50 mcg twice per day
Other Names:
  • Seravent
  • Advair
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:
  • Seravent
  • Advair
Drug: Fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
Other Names:
  • flovent
  • advair

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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
  • 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
  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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214019     History of Changes
Other Study ID Numbers: H-2003-0469 
Study First Received: September 13, 2005
Results First Received: August 17, 2011
Last Updated: June 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
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 December 02, 2016