Placebo Versus Antibiotics in Acute Exacerbations of COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: doxycycline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical Center Alkmaar

Official(s) and/or principal investigator(s):
Johannes MA Daniels, drs, Principal Investigator, Affiliation: Pulmo-science
Dominic Snijders, drs, Principal Investigator, Affiliation: Pulmo-science

Overall contact:
Johannes MA Daniels, drs, Phone: +31725482750, Email: hans_daniels@zonnet.nl

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.

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

Official title: The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Clinical efficacy at the end of treatment

Secondary outcome:

treatment failure at follow up

number of exacerbation

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- acute exacerbation of COPD type I or II according to GOLD

- ability to perform longfunctiontests

- 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.

- Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction

etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).

- Cystic fibrosis

- Tuberculosis.

- Impaired renal function (creatinine clearance < 20 ml/min).

Johannes MA Daniels, drs, Phone: +31725482750, Email: hans_daniels@zonnet.nl

Medisch centrum Alkmaar, Alkmaar, Noord-holland 1815 JD, Netherlands; Recruiting
Dominic Snijders, drs, Principal Investigator

Starting date: July 2002
Ending date: August 2005
Last updated: September 7, 2006