Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease (TRANCE)

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Carl Llor, Catalan Society of Family Medicine
ClinicalTrials.gov Identifier:
NCT00495586
First received: July 2, 2007
Last updated: March 11, 2012
Last verified: March 2012
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Catalan Society of Family Medicine:

Primary Outcome Measures:
  • Number of Patients Who Were Cured [ Time Frame: Day 9-11 ] [ Designated as safety issue: Yes ]
    Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability


Secondary Outcome Measures:
  • Number of Days Till the Next Exacerbation [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 318
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo pills t.i.d. for 8 days
Drug: Placebo
One pill to be taken every eight hours for 8 days
Other Name: It's placebo
Active Comparator: Amoxycillin and clavulanic acid
Amoxycillin and clavulanate t.i.d. for 8 days
Drug: Amoxicillin and clavulanic acid
500-125 mg to be taken every eight hours for 8 days
Other Name: Augmentine 500-125 mg 24 pills

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495586

Locations
Spain
Primary Healthcare Center La Marina
Barcelona, Catalonia, Spain, 08038
Hospital Clínic
Barcelona, Catalonia, Spain, 08036
Primary Healthcare Center Figueres
Figueres, Catalonia, Spain, 17600
Primary Healthcare Center Montilivi
Girona, Catalonia, Spain, 17003
Primary Healthcare Center Girona-4
Girona, Catalonia, Spain, 17007
Primary Healthcare Centre Breda-Hostalric
Hostalric, Catalonia, Spain, 17450
Primary Healthcare Center Lleida
Lleida, Catalonia, Spain, 25001
Primary Healthcare Centre Molins de Rei
Molins de Rey, Catalonia, Spain, 08750
Primary Healthcare Centre Olot
Olot, Catalonia, Spain, 17800
Primary Healthcare Center Reus-3
Reus, Catalonia, Spain, 43203
Primary Healthcare Center Les Muralles
Tarragona, Catalonia, Spain, 43003
Primary Healthcare Centre Jaume I
Tarragona, Catalonia, Spain, 43005
Primary Healthcare Center Valls Urbà
Valls, Catalonia, Spain, 43600
Sponsors and Collaborators
Catalan Society of Family Medicine
Fondo de Investigacion Sanitaria
Investigators
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
  More Information

No publications provided by Catalan Society of Family Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carl Llor, Doctor, Catalan Society of Family Medicine
ClinicalTrials.gov Identifier: NCT00495586     History of Changes
Other Study ID Numbers: P06/31
Study First Received: July 2, 2007
Results First Received: January 8, 2012
Last Updated: March 11, 2012
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Catalan Society of Family Medicine:
COPD
Antibiotics

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014