Phase 4 Completed N=318 Randomized Double-blind Treatment

Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00495586 ↗

Enrolled (actual)

318

Serious AEs

0.0%

Results posted

Mar 2012

Primary outcomePrimary: Number of Patients Who Were Cured — 91; 117 Participants — p=<0.05

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.