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The Effect of Salmeterol on Eosinophil (EOS) Function

NCT ID: NCT00214019

Last Updated: 2017-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo Diskus

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo diskus

Salmeterol Diskus 50 mcg twice per day

Salmeterol Diskus 50 mcg twice per day

Group Type EXPERIMENTAL

salmeterol

Intervention Type DRUG

salmeterol diskus 50 mcg twice per day

Placebo diskus, fluticasone

placebo diskus, fluticasone MDI 88 mcg twice per day

Group Type EXPERIMENTAL

Fluticasone

Intervention Type DRUG

placebo diskus, fluticasone MDI 88 mcg twice per day

Salmeterol, Fluticasone

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

Group Type EXPERIMENTAL

salmeterol

Intervention Type DRUG

salmeterol diskus 50 mcg twice per day

Fluticasone

Intervention Type DRUG

placebo diskus, fluticasone MDI 88 mcg twice per day

Interventions

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salmeterol

salmeterol diskus 50 mcg twice per day

Intervention Type DRUG

Fluticasone

placebo diskus, fluticasone MDI 88 mcg twice per day

Intervention Type DRUG

Placebo

placebo diskus

Intervention Type DRUG

Other Intervention Names

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Seravent Advair flovent advair no drug comparator treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Busse, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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H-2003-0469

Identifier Type: -

Identifier Source: org_study_id