The Effect of Salmeterol on Eosinophil (EOS) Function

Allergic Asthma Clinical Trial

Official title:

The Effect of Salmeterol on Eosinophil (EOS) Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214019
• Other study ID #: H-2003-0469
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 17, 2017
• Start date: November 2003
• Est. completion date: January 2008

Study information

• Verified date: October 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma

Intervention

Drug:
• salmeterol
salmeterol diskus 50 mcg twice per day
• Fluticasone
placebo diskus, fluticasone MDI 88 mcg twice per day
• Placebo
placebo diskus

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum Eosinophils (EOS) 24 Hours Post 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