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

This study has been completed.

First Received: September 9, 2005 Last Updated: September 26, 2008 History of Changes

Sponsored by:	Medical Center Alkmaar
Information provided by:	Medical Center Alkmaar
ClinicalTrials.gov Identifier:	NCT00170222

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: doxycycline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:

Clinical efficacy at the end of treatment

Secondary Outcome Measures:

Treatment failure at follow up
Number of exacerbation

Estimated Enrollment:	258
Study Start Date:	July 2002
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170222

Locations

Netherlands, Noord-holland
Medisch centrum Alkmaar
Alkmaar, Noord-holland, Netherlands, 1815 JD

Sponsors and Collaborators

Medical Center Alkmaar

Investigators

Principal Investigator:	Johannes MA Daniels, drs	Pulmo-science
Principal Investigator:	Dominic Snijders, drs	Pulmo-science

More Information

No publications provided

Study ID Numbers:	M02-007
Study First Received:	September 9, 2005
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00170222 History of Changes
Health Authority:	Netherlands: Dutch Health Care Inspectorate

Keywords provided by Medical Center Alkmaar:

Acute bronchitis
antibiotics

Study placed in the following topic categories:

Antimalarials
Anti-Bacterial Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Bronchitis
Doxycycline
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Respiration Disorders
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Lung Diseases, Obstructive

Antiparasitic Agents
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Doxycycline
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 02, 2009