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Completed

NCT Number: NCT00495586

Effectiveness of Antibiotic Therapy for Exacerbations of 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic, Barcelona, Catalonia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

One pill to be taken every eight hours for 8 days

Other names: It's placebo

Amoxicillin and Clavulanic Acid

Drug

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

Other names: Augmentine 500-125 mg 24 pills

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)

Other

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Official study title

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

Acronym: TRANCE

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Jul 3, 2007
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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