Study Evaluating Etanercept in Moderate to Severe Asthma

NCT ID: NCT00141791

Last Updated: 2009-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-07-31

Brief Summary

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The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Etanercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe persistent asthma for at least 1 year
* Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
* Subjects must be on a high-dose inhaled corticosteroid (ICS)

Exclusion Criteria

* Previous treatment with etanercept
* Current use of cigarettes
* Significant concurrent medical conditions at the time of screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Birmingham, Alabama, United States

Site Status

Denver, Colorado, United States

Site Status

Sarasota, Florida, United States

Site Status

Tallahassee, Florida, United States

Site Status

Valrico, Florida, United States

Site Status

Covington, Louisiana, United States

Site Status

Wheaton, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Rockville Centre, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Portland, Oregon, United States

Site Status

Richmond, Virginia, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Holgate ST, Noonan M, Chanez P, Busse W, Dupont L, Pavord I, Hakulinen A, Paolozzi L, Wajdula J, Zang C, Nelson H, Raible D. Efficacy and safety of etanercept in moderate-to-severe asthma: a randomised, controlled trial. Eur Respir J. 2011 Jun;37(6):1352-9. doi: 10.1183/09031936.00063510. Epub 2010 Nov 25.

Reference Type DERIVED
PMID: 21109557 (View on PubMed)

Other Identifiers

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0881A8-205

Identifier Type: -

Identifier Source: org_study_id

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