Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
Phase 4
Withdrawn
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo (matching)
- Registration Number
- NCT00952861
- Lead Sponsor
- Odense University Hospital
- Brief Summary
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- Age above 50 years
- History of smoking
- History of COPD
- Antibiotics for 24 hours
- At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
- Informed consent
Exclusion Criteria
- Pneumonia
- Antibiotics for more than 36 hours
- Antibiotics for other infection
- Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
- Malignancy
- Other pulmonary disease
- Immune deficiency
- Not able to tolerate doxycycline
- Severe heart, liver or kidney disease
- Epilepsia
- Not stable 24 hours after hospital admission
- Need for assisted ventilation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (matching) Matching placebo QD i 5 days Doxycycline Doxycycline Doxycycline 200 mg QD in 5 days
- Primary Outcome Measures
Name Time Method 6 minutes walking distance Day 14
- Secondary Outcome Measures
Name Time Method Time to next episode of acute exacerbation Days 14, 30, 90 and 180
Trial Locations
- Locations (1)
Odense University Hospital
🇩🇰Odense, Denmark