Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease

NCT00495586 | Completed Phase 4 Results

• 1 other identifier: P06/31
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Were Cured

  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 Outcomes (1)

• Number of Days Till the Next Exacerbation

  One year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo pills t.i.d. for 8 days

Drug: Placebo

Amoxycillin and clavulanic acid

ACTIVE COMPARATOR

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

Drug: Amoxicillin and clavulanic acid

Interventions

Placebo DRUG

One pill to be taken every eight hours for 8 days

Also known as: It's placebo

Placebo

Amoxicillin and clavulanic acid DRUG

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

Also known as: Augmentine 500-125 mg 24 pills

Amoxycillin and clavulanic acid

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC): lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (13)

Hospital Clínic

Barcelona, Catalonia, 08036, Spain

Location

Primary Healthcare Center La Marina

Barcelona, Catalonia, 08038, Spain

Location

Primary Healthcare Center Figueres

Figueres, Catalonia, 17600, Spain

Location

Primary Healthcare Center Montilivi

Girona, Catalonia, 17003, Spain

Location

Primary Healthcare Center Girona-4

Girona, Catalonia, 17007, Spain

Location

Primary Healthcare Centre Breda-Hostalric

Hostalric, Catalonia, 17450, Spain

Location

Primary Healthcare Center Lleida

Lleida, Catalonia, 25001, Spain

Location

Primary Healthcare Centre Molins de Rei

Molins de Rey, Catalonia, 08750, Spain

Location

Primary Healthcare Centre Olot

Olot, Catalonia, 17800, Spain

Location

Primary Healthcare Center Reus-3

Reus, Catalonia, 43203, Spain

Location

Primary Healthcare Center Les Muralles

Tarragona, Catalonia, 43003, Spain

Location

Primary Healthcare Centre Jaume I

Tarragona, Catalonia, 43005, Spain

Location

Primary Healthcare Center Valls Urbà

Valls, Catalonia, 43600, Spain

Location

Related Publications (2)

• 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.

  PMID: 23807094 DERIVED

• 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.

  PMID: 22923662 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

The required sample size could not be achieved. This clinical trial was only partially funded by an independent academic institution without any other source of funding. However, due differences obtained the sample size allowed for a power of 80%.

Results Point of Contact

• Title: Carl Llor
• Organization: CAMFIC

carles.llor@urv.cat

+34 3011777

Study Officials

• Carl Llor, Doctor

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

  PRINCIPAL INVESTIGATOR

• Marc Miravitlles, Doctor

  Hospital Clinic

  STUDY DIRECTOR

• Ana Moragas, Family doc.

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: March 13, 2012
• Results First Posted: March 13, 2012

Record last verified: 2012-03

Locations

ES (13)