Study Evaluating Etanercept in Moderate to Severe Asthma

Wyeth is now a wholly owned subsidiary of Pfizer120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Asthma

Interventions

EtanerceptDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Sarasota, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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