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

This study has been completed.
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00170222
First received: September 9, 2005
Last updated: September 26, 2008
Last verified: September 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

Resource links provided by NLM:


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
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 by Medical Center Alkmaar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00170222     History of Changes
Other Study ID Numbers: M02-007
Study First Received: September 9, 2005
Last Updated: September 26, 2008
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Medical Center Alkmaar:
Acute bronchitis
antibiotics

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 17, 2014