The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Medical Center Alkmaar1 site in 1 country258 target enrollmentJuly 2002

ConditionsChronic Obstructive Pulmonary Disease

Drugsdoxycycline

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Medical Center Alkmaar
Enrollment: 258
Locations: 1
Primary Endpoint: Clinical efficacy at the end of treatment
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.

The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

August 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical Center Alkmaar

Eligibility Criteria

Inclusion Criteria

•Acute exacerbation of COPD type I or II according to GOLD
•Ability to perform lung function tests
•Ability to take oral medication

Exclusion Criteria

•Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
•Pretreatment ( \> 24 hours) with an antibiotic for the present exacerbation.
•Pretreatment with corticosteroids (\>30 mg for more than 4 days) for the present exacerbation.
•Progression or new radiographic abnormalities on the chest X-ray.
•Severe exacerbation that required mechanical ventilation.
•History of bronchiectasis
•Recent or unresolved lung malignancy.
•Other disease likely to require antibiotic therapy.
•Significant gastrointestinal or other conditions that may affect study drug absorption.
•Class III or IV congestive heart failure or stroke.