Clinical trial NCT00495586: Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Antibiotics
Lead sponsor: Catalan Society of Family Medicine
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2007-07-03
Enrollment: 318
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Number of Patients Who Were Cured
timeFrame: Day 9-11
Secondary outcomes:
measure: Number of Days Till the Next Exacerbation
timeFrame: One year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Healthcare Center La Marina
state: Catalonia
city: Figueres
country: Spain
facility: Primary Healthcare Center Figueres
state: Catalonia
city: Girona
country: Spain
facility: Primary Healthcare Center Montilivi
state: Catalonia
city: Girona
country: Spain
facility: Primary Healthcare Center Girona-4
state: Catalonia
city: Hostalric
country: Spain
facility: Primary Healthcare Centre Breda-Hostalric
state: Catalonia
city: Lleida
country: Spain
facility: Primary Healthcare Center Lleida
state: Catalonia
city: Molins de Rey
country: Spain
facility: Primary Healthcare Centre Molins de Rei
state: Catalonia
city: Olot
country: Spain
facility: Primary Healthcare Centre Olot
state: Catalonia
city: Reus
country: Spain
facility: Primary Healthcare Center Reus-3
state: Catalonia
city: Tarragona
country: Spain
facility: Primary Healthcare Center Les Muralles
state: Catalonia
city: Tarragona
country: Spain
facility: Primary Healthcare Centre Jaume I
state: Catalonia
city: Valls
country: Spain
facility: Primary Healthcare Center Valls Urbà
state: Catalonia
Study officials:
affiliation: Catalan Society of Family Medicine
name: Carl Llor, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic
name: Marc Miravitlles, Doctor
role: STUDY_DIRECTOR
affiliation: Catalan Society of Family Medicine
name: Ana Moragas, Family doc.
role: STUDY_DIRECTOR
References:
citation: Miravitlles M, Moragas A, Hernandez S, Bayona C, Llor C. Is it possible to identify exacerbations of mild to moderate COPD that do not require antibiotic treatment? Chest. 2013 Nov;144(5):1571-1577. doi: 10.1378/chest.13-0518.
citation: Llor C, Moragas A, Hernandez S, Bayona C, Miravitlles M. Efficacy of antibiotic therapy for acute exacerbations of mild to moderate chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Oct 15;186(8):716-23. doi: 10.1164/rccm.201206-0996OC. Epub 2012 Aug 23.