Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Medical Center Alkmaar

Status and phase

Completed

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: doxycycline

Study type

Interventional

Funder types

Other

Identifiers

NCT00170222

M02-007

Details and patient eligibility

About

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.

Enrollment

258 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.
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).