Chronic Obstructive Pulmonary Disease Clinical Trial
— TRANCEOfficial title:
Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the effectiveness of antibiotic therapy for patients with acute exacerbations of mild-to-moderate chronic obstructive pulmonary disease.
Status | Completed |
Enrollment | 318 |
Est. completion date | July 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Acute exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of - patients older than 40 years old, - smokers or ex-smokers of more than 10 pack-years, - with COPD and FEV1 greater than 50%, diagnosed by spirometry and a predicted ratio FEV1/FVC<0.7%. Exclusion Criteria: - Severe COPD (FEV1<50%) - Pneumonia - Active neoplasm - Tracheotomy - Criteria for hospitalisation - Patients previously being on antibiotics - Immunodepressed patients - History of hypersensitivity to beta-lactams or intolerance to clavulanate - Enrollment in other clinical trials - Patients who refuse to take part in this study - Patients who have not had a spirometry test for the past two years |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic | Barcelona | Catalonia |
Spain | Primary Healthcare Center La Marina | Barcelona | Catalonia |
Spain | Primary Healthcare Center Figueres | Figueres | Catalonia |
Spain | Primary Healthcare Center Girona-4 | Girona | Catalonia |
Spain | Primary Healthcare Center Montilivi | Girona | Catalonia |
Spain | Primary Healthcare Centre Breda-Hostalric | Hostalric | Catalonia |
Spain | Primary Healthcare Center Lleida | Lleida | Catalonia |
Spain | Primary Healthcare Centre Molins de Rei | Molins de Rey | Catalonia |
Spain | Primary Healthcare Centre Olot | Olot | Catalonia |
Spain | Primary Healthcare Center Reus-3 | Reus | Catalonia |
Spain | Primary Healthcare Center Les Muralles | Tarragona | Catalonia |
Spain | Primary Healthcare Centre Jaume I | Tarragona | Catalonia |
Spain | Primary Healthcare Center Valls Urbà | Valls | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Catalan Society of Family Medicine | Fondo de Investigacion Sanitaria |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Who Were Cured | Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability | Day 9-11 | Yes |
Secondary | Number of Days Till the Next Exacerbation | For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days. | One year | Yes |
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