The Effect of Salmeterol on Eosinophil (EOS) Function

University of Wisconsin (UW)

Status: Completed

Conditions: Allergic Asthma

Treatments: Drug: salmeterol; Drug: Fluticasone; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00214019

H-2003-0469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 4 patient groups, including a placebo group

Placebo Diskus

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: Placebo

Salmeterol Diskus 50 mcg twice per day

Experimental group

Description:

Salmeterol Diskus 50 mcg twice per day

Treatment:

Drug: salmeterol

Placebo diskus, fluticasone

Experimental group

Description:

placebo diskus, fluticasone MDI 88 mcg twice per day

Treatment:

Drug: Fluticasone

Salmeterol, Fluticasone

Experimental group

Description:

Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day

Treatment:

Drug: Fluticasone

Drug: salmeterol