Phase 3
Completed N=396
A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Source: ClinicalTrials.gov NCT00254566 ↗Enrolled (actual)
396
Serious AEs
—
Results posted
Sep 2009
Primary outcomePrimary: Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) — 93.0; 94.2; 7.0; 5.8 percent
Summary
This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population) |
93.0; 94.2; 7.0; 5.8 | — |
| SECONDARY Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set) |
88.4; 90.9; 11.6; 9.1 | — |
| SECONDARY Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set) |
88.4; 90.9; 11.6; 9.1 | — |
| SECONDARY Percentage of Bacteriologic Response at Test of Cure Visit |
96; 96.7; 4; 3.3 | — |
| SECONDARY Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence |
152; 204 | 0.159 |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score |
-0.76; -0.71 | 0.57 |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score |
-0.99; -0.96 | 0.81 |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score |
-0.61; -0.52 | 0.385 |
| SECONDARY Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score |
-0.60; -0.54 | 0.62 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
- Production of purulent sputum as defined by Gram stained sputum specimen
- Presence of all of the following:
- Increased sputum production
- Increased dyspnea
- Increased cough
- At least two exacerbations of AECB in the past 12 months
- Documented FEV1 less than 80% of predicted
Exclusion Criteria
- A chest radiograph consistent with pneumonia
- Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
Data sourced from ClinicalTrials.gov (NCT00254566). 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.