Phase 4
N=318
Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00495586 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Number of Patients Who Were Cured — 91; 117 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Amoxicillin and clavulanic acid (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Were Cured |
91; 117 | <0.05 sig |
| SECONDARY Number of Days Till the Next Exacerbation |
233; 160 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00495586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.