Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease

NCT ID: NCT00495586

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo pills t.i.d. for 8 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One pill to be taken every eight hours for 8 days

Amoxycillin and clavulanic acid

Amoxycillin and clavulanate t.i.d. for 8 days

Group Type: ACTIVE_COMPARATOR

Amoxicillin and clavulanic acid

Intervention Type: DRUG

500-125 mg to be taken every eight hours for 8 days

Interventions

Placebo

One pill to be taken every eight hours for 8 days

Intervention Type: DRUG

Amoxicillin and clavulanic acid

500-125 mg to be taken every eight hours for 8 days

Intervention Type: DRUG

Other Intervention Names

It's placebo; Augmentine 500-125 mg 24 pills

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Catalan Society of Family Medicine

OTHER

Sponsor Role: lead

Responsible Party

Carl Llor

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl Llor, Doctor

Role: PRINCIPAL_INVESTIGATOR

Catalan Society of Family Medicine

Marc Miravitlles, Doctor

Role: STUDY_DIRECTOR

Hospital Clinic

Ana Moragas, Family doc.

Role: STUDY_DIRECTOR

Catalan Society of Family Medicine

Locations

Hospital Clínic

Barcelona, Catalonia, Spain

Primary Healthcare Center La Marina

Barcelona, Catalonia, Spain

Primary Healthcare Center Figueres

Figueres, Catalonia, Spain

Primary Healthcare Center Montilivi

Girona, Catalonia, Spain

Primary Healthcare Center Girona-4

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, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 23807094 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22923662 (View on PubMed)

Other Identifiers

P06/31

Identifier Type: -

Identifier Source: org_study_id