We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Salmeterol on Eosinophil (EOS) Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00214019
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 8, 2016
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Allergic Asthma Drug: salmeterol Drug: Fluticasone Drug: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Salmeterol on Eosinophil (EOS) Function
Actual Study Start Date : November 2003
Primary Completion Date : January 2008
Study Completion Date : January 2008


Arms and Interventions

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
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


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 21, 2005    Key Record Dates
Results First Posted: August 8, 2016
Last Update Posted: November 21, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics