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TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

NCT00789997 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-04-11

Study results available
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Summary

The purpose of this study is to determine whether treatment with antibiotics plus a TNFalpha antagonist will provide more effective treatment for acute COPD exacerbation compared to the current standard treatment of antibiotics plus prednisone.

Conditions

  • COPD Exacerbation

Interventions

DRUG

Prednisone

prednisone 40 mg daily for 10 days or placebo prednisone

DRUG

Etanercept

etanercept 50 mg subcutaneous given on the day of randomization and one week later or placebo subcutaneous injection

DRUG

levofloxacin

Levofloxacin 750 mg daily for 10 days.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Shawn Aaron, MD, MSc · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-08-31
Completion
2011-10-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789997 on ClinicalTrials.gov