Status:
COMPLETED
Placebo Versus Antibiotics in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Medical Center Alkmaar
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- Acute exacerbation of COPD type I or II according to GOLD
- Ability to perform lung function tests
- Ability to take oral medication
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00170222
Start Date
July 1 2002
End Date
August 1 2008
Last Update
September 29 2008
Active Locations (1)
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1
Medisch centrum Alkmaar
Alkmaar, North Holland, Netherlands, 1815 JD