Study Evaluating Etanercept in Moderate to Severe Asthma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141791

Enrollment

120

Registered

2005-09-01

Start date

2005-05-31

Completion date

2006-07-31

Last updated

2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Anti-Asthmatic Agents, Receptors, Tumor Necrosis Factor

Brief summary

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.

Interventions

DRUGEtanercept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Peak expiratory flow rate, Asthma control questionnaire, Asthma exacerbations.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026