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Completed

NCT Number: NCT00141791

Study Evaluating Etanercept in Moderate to Severe Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. Change in FEV1% predicted from baseline to week 12 (before bronchodilator administration).

Secondary outcomes

  1. Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 25mg Twice Weekly in Subjects With Moderate to Severe Persistent Asthma

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Aug 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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