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Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Study NCT00170222   Information provided by Medical Center Alkmaar
First Received: September 9, 2005   Last Updated: September 26, 2008   History of Changes

September 9, 2005
September 26, 2008
July 2002
August 2008   (final data collection date for primary outcome measure)
Clinical efficacy at the end of treatment
Same as current
Complete list of historical versions of study NCT00170222 on ClinicalTrials.gov Archive Site
  • Treatment failure at follow up
  • Number of exacerbation
Same as current
 
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients

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.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Chronic Obstructive Pulmonary Disease
Drug: doxycycline
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
258
August 2008
August 2008   (final data collection date for primary outcome measure)

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).
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00170222
 
M02-007
Medical Center Alkmaar
 
Principal Investigator: Johannes MA Daniels, drs Pulmo-science
Principal Investigator: Dominic Snijders, drs Pulmo-science
Medical Center Alkmaar
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP