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

The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00170222

Enrollment

258

Registered

2005-09-15

Start date

2002-07-31

Completion date

2008-08-31

Last updated

2008-09-29

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Acute bronchitis, antibiotics

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.

Interventions

DRUGdoxycycline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
Clinical efficacy at the end of treatment	—

Secondary

Measure	Time frame
Treatment failure at follow up	—
Number of exacerbation	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026