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Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease

Information source: Catalan Society of Family Medicine
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Placebo (Drug); Amoxicillin and clavulanic acid (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Catalan Society of Family Medicine

Official(s) and/or principal investigator(s):
Carl Llor, Doctor, Principal Investigator, Affiliation: Catalan Society of Family Medicine
Marc Miravitlles, Doctor, Study Director, Affiliation: Hospital Clinic
Ana Moragas, Family doc., Study Director, Affiliation: Catalan Society of Family Medicine

Overall contact:
Ana Moragas, Family doc., Phone: +34 600072170, Email: amoragasm@medynet.com

Summary

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.

Clinical Details

Official title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Cure rate

Secondary outcome: Number of days till the next exacerbation

Detailed description: Antibiotics are usually prescribed for acute exacerbations of chronic obstructive pulmonary disease (COPD) even though their benefit in mild-to-moderate COPD is not demonstrated. The aim of this study is to assess the effectiveness of antibiotic therapy for exacerbations of COPD, what clinical variables are associated with an improved clinical response with antibiotic therapy with respect to placebo and to identify which patients might recover from an acute exacerbation without antibiotic therapy. Methodology: prospective, randomised, double blind, placebo-controlled clinical trial, in which exacerbations (at least one criterion present: increase of dyspnoea, increase of sputum production and/or increase of purulence) of patients older than 40 yr., 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%), active neoplasm, tracheotomy, pneumonia, hospitalization criteria, patients previously being on antibiotics, immunodepressed, history of hypersensitivity to beta-lactams or intolerance to clavulanate, enrollment in other clinical trials, patients who refuse to take part in this study, and patients who have not had a spirometry test for the past two years. Sample size: 677 patients. Interventions: first visit: the patient will be given details of the clinical trial and will be asked to sign informed consent; other data: sputum color, chest X-ray ordered to rule out pneumonia, C-reactive protein levels, and peak flow measurement. The patient will be randomised to receive amoxicillin plus clavulanate or placebo and will be scheduled to return for a 2nd follow-up visit after 3 or 4 days to assess the clinical response and peak flow measurements and to rule out any worsening of the condition. Third visit: scheduled after 9-11 days to assess the clinical response, drug-compliance and peak flow measurement. Fourth visit after 15-20 days for clinical assessment and to observe whether any relapses have occurred. Date of the following exacerbation will be recorded.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ana Moragas, Family doc., Phone: +34 600072170, Email: amoragasm@medynet.com

Hospital Clínic, Barcelona, Catalonia 08036, Spain; Completed

Primary Healthcare Center La Marina, Barcelona, Catalonia 08038, Spain; Completed

Primary Healthcare Center Figueres, Figueres, Catalonia 17600, Spain; Completed

Primary Healthcare Center Montilivi, Girona, Catalonia 17003, Spain; Completed

Primary Healthcare Center Girona-4, Girona, Catalonia 17007, Spain; Completed

Primary Healthcare Centre Breda-Hostalric, Hostalric, Catalonia 17450, Spain; Completed

Primary Healthcare Center Lleida, Lleida, Catalonia 25001, Spain; Completed

Primary Healthcare Centre Molins de Rei, Molins de Rey, Catalonia 08750, Spain; Completed

Primary Healthcare Centre Olot, Olot, Catalonia 17800, Spain; Completed

Primary Healthcare Center Reus-3, Reus, Catalonia 43203, Spain; Completed

Primary Healthcare Center Les Muralles, Tarragona, Catalonia 43003, Spain; Completed

Primary Healthcare Centre Jaume I, Tarragona, Catalonia 43005, Spain; Recruiting
Ana Moragas, Family doc., Phone: +34600072170, Email: amoragasm@meditex.es
Silvia Hernandez, Doctor, Sub-Investigator
Yvonne Fernandez, Family doc., Sub-Investigator
Aitor Alfaro, Family doc., Sub-Investigator
Manel Perez, Family doc., Sub-Investigator
Carl Llor, Doctor, Principal Investigator

Primary Healthcare Center Valls Urbà, Valls, Catalonia 43600, Spain; Completed

Additional Information

Starting date: October 2007
Last updated: July 11, 2011

Page last updated: December 08, 2011

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