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Sponsors and Collaborators: |
Catalan Society of Family Medicine Fondo de Investigacion Sanitaria |
Information provided by: | Catalan Society of Family Medicine |
ClinicalTrials.gov Identifier: | NCT00495586 |
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.
Condition | Intervention | Phase |
Chronic Obstructive Pulmonary Disease |
Drug: Placebo Drug: Amoxicillin and clavulanic acid |
Phase IV |
MedlinePlus related topics: | Antibiotics COPD (Chronic Obstructive Pulmonary Disease) |
Drug Information available for: | Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clavulanic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-Moderate Chronic Obstructive Pulmonary Disease |
Estimated Enrollment: | 677 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2010 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Placebo Comparator
Placebo pills t.i.d. for 8 days
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Drug: Placebo
One pill to be taken every eight hours for 8 days
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B: Active Comparator
Amoxycillin and clavulanate t.i.d. for 8 days
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Drug: Amoxicillin and clavulanic acid
500-125 mg to be taken every eight hours for 8 days
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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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ana Moragas, Family doc. | +34 600072170 | amoragasm@medynet.com |
Contact: Marc Miravitlles, Doctor | +34 932263911 | marcm@separ.es |
Spain, CAtalonia | |||||
Primary Healthcare Center Valls Urbà | Not yet recruiting | ||||
Valls, CAtalonia, Spain, 43600 | |||||
Principal Investigator: Carolina Bayona, Family doc. | |||||
Sub-Investigator: Dolors Llovet, Family doc. | |||||
Spain, Catalonia | |||||
Primary Healthcare Centre Jaume I | Recruiting | ||||
Tarragona, Catalonia, Spain, 43005 | |||||
Contact: Ana Moragas, Family doc. +34600072170 amoragasm@meditex.es | |||||
Sub-Investigator: Silvia Hernandez, Doctor | |||||
Sub-Investigator: Yvonne Fernandez, Family doc. | |||||
Sub-Investigator: Aitor Alfaro, Family doc. | |||||
Sub-Investigator: Manel Perez, Family doc. | |||||
Principal Investigator: Carl Llor, Doctor | |||||
Primary Healthcare Center La Marina | Not yet recruiting | ||||
Barcelona, Catalonia, Spain, 08038 | |||||
Principal Investigator: Josep Maria Cots, Family doc. | |||||
Sub-Investigator: José Miguel Baena, Family doc. | |||||
Primary Healthcare Centre Breda-Hostalric | Not yet recruiting | ||||
Hostalric, Catalonia, Spain, 17450 | |||||
Principal Investigator: José Paredes, Family doc. | |||||
Primary Healthcare Center Montilivi | Not yet recruiting | ||||
Girona, Catalonia, Spain, 17003 | |||||
Principal Investigator: Carlos Cerezo, Family doc. | |||||
Primary Healthcare Center Reus-3 | Not yet recruiting | ||||
Reus, Catalonia, Spain, 43203 | |||||
Principal Investigator: Ramon Descarrega, Family doc. | |||||
Sub-Investigator: Manuel Prieto, Family doc. | |||||
Hospital Clínic | Not yet recruiting | ||||
Barcelona, Catalonia, Spain, 08036 | |||||
Principal Investigator: Marc Miravitlles, Pneumologist | |||||
Primary Healthcare Centre Olot | Not yet recruiting | ||||
Olot, Catalonia, Spain, 17800 | |||||
Principal Investigator: Jacint Caula, Family doc. | |||||
Primary Healthcare Center Girona-4 | Not yet recruiting | ||||
Girona, Catalonia, Spain, 17007 | |||||
Principal Investigator: Anna Picas, Family doc. | |||||
Primary Healthcare Center Lleida | Not yet recruiting | ||||
Lleida, Catalonia, Spain, 25001 | |||||
Principal Investigator: Jesus Pujol, Family doc. | |||||
Primary Healthcare Center Les Muralles | Not yet recruiting | ||||
Tarragona, Catalonia, Spain, 43003 | |||||
Principal Investigator: Elena Taverna, Family doc. | |||||
Sub-Investigator: Ramon Monegal, Family doc. | |||||
Primary Healthcare Center Figueres | Not yet recruiting | ||||
Figueres, Catalonia, Spain, 17600 | |||||
Principal Investigator: Zoila Bastardo, Family doc. |
Catalan Society of Family Medicine |
Fondo de Investigacion Sanitaria |
Principal Investigator: | Carl Llor, Doctor | Catalan Society of Family Medicine |
Study Director: | Marc Miravitlles, Doctor | Hospital Clinic |
Study Director: | Ana Moragas, Family doc. | Catalan Society of Family Medicine |
Responsible Party: | Catalan Institute of Health ( Ramon Morera ) |
Study ID Numbers: | P06/31 |
First Received: | July 2, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00495586 |
Health Authority: | Spain: Ministry of Health and Consumption |
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