Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
Verified date | September 2008 |
Source | Medical Center Alkmaar |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Dutch Health Care Inspectorate |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 258 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Medisch centrum Alkmaar | Alkmaar | Noord-holland |
Lead Sponsor | Collaborator |
---|---|
Medical Center Alkmaar |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical efficacy at the end of treatment | |||
Secondary | Treatment failure at follow up | |||
Secondary | Number of exacerbation |
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