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

March 11, 2012 updated by: Carl Llor, Catalan Society of Family Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08036
        • Hospital Clinic
      • Barcelona, Catalonia, Spain, 08038
        • Primary Healthcare Center La Marina
      • Figueres, Catalonia, Spain, 17600
        • Primary Healthcare Center Figueres
      • Girona, Catalonia, Spain, 17003
        • Primary Healthcare Center Montilivi
      • Girona, Catalonia, Spain, 17007
        • Primary Healthcare Center Girona-4
      • Hostalric, Catalonia, Spain, 17450
        • Primary Healthcare Centre Breda-Hostalric
      • Lleida, Catalonia, Spain, 25001
        • Primary Healthcare Center Lleida
      • Molins de Rey, Catalonia, Spain, 08750
        • Primary Healthcare Centre Molins de Rei
      • Olot, Catalonia, Spain, 17800
        • Primary Healthcare Centre Olot
      • Reus, Catalonia, Spain, 43203
        • Primary Healthcare Center Reus-3
      • Tarragona, Catalonia, Spain, 43003
        • Primary Healthcare Center Les Muralles
      • Tarragona, Catalonia, Spain, 43005
        • Primary Healthcare Centre Jaume I
      • Valls, Catalonia, Spain, 43600
        • Primary Healthcare Center Valls Urbà

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Augmentine 500-125 mg 24 pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Were Cured
Time Frame: Day 9-11
Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability
Day 9-11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days Till the Next Exacerbation
Time Frame: One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalan Society of Family Medicine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

July 2, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 11, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06/31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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