Acute exacerbation of chronic ostructive pulmonary disease in hospitalized patients. All patients receive "standard of care", and 1 day of intravenous antibiotics. In addition patients are randomized to treatment with Vibradox 200 mg QD in 5 days or matching placebo. The primary outcome variable is 6 minutes walking distance at day 14 after hospitalization. MedDRA version: 9.1 Level: LLT Classification code 10056971 Term: Infective exacerbation of chronic obstructive airways disease
Conditions
Interventions
Trade Name: Vibradox
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Department of Infetious Diseases, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 50 years 2) History of smoking 3) History of COPD 4) Symptoms of acute exacerbation in COPD Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pneumonia 2) Antibiotics given for >= 36 hours before admission 3) Patients in whom doxycyklin is contraindicated 4) Patients with cancer, epilepsia or severe heart, kidney og liver dysfunction 5) Patients in terminal phase of COPD 6) Patients with tuberculosis or aspergillosis 7) Patients in need for intensive care or with progressive disease within the first 24 hours of hospitalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether antibiotics (doxycyklinn) improves recovery as measured by 6 minutes walking distance ad days 7 and 14 after an episode of acute exacerbation in chronic pulmonary disease.;Secondary Objective: To investigate whether antibiotics (doxycyklin) improves: 1) Duration of hospitalization 2) Duration of pulmonary symptoms 3) Clinical and microbiological cure 4) Pulmonary function 5) Mortality 6) Time to new epsiode 7) Quality of Life 8) Side effects;Primary end point(s): 6 minute walking distance at day 14 | — |
Countries
Denmark
Outcome results
None listed