Status:
UNKNOWN
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
Lead Sponsor:
Odense University Hospital
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to: * A slower rate of decline in for...
Detailed Description
Study Population: Patients with moderate to severe chronic obstructive lung disease. Trial Phase: IV Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial. Study M...
Eligibility Criteria
Inclusion
- Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
- Current or ex-smoker
- Postbronchodilator FEV1 \< 60% in stable condition (\> 4 weeks after hospitalisation)
- \< 300 ml bronchodilator reversibility in FEV1
Exclusion
- Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
- Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
- Patients with pulmonary malignancy
- Patients with other pulmonary diseases than COLD.
- Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
- Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
- Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
- Patients with known allergy or intolerance to azithromycin
- Pregnant or breastfeeding women
- Manifest heart, liver or renal insufficiency
- Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00132860
Start Date
May 1 2001
End Date
December 1 2007
Last Update
October 19 2005
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000 C