Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis.

Abstract

BACKGROUND:

Clarithromycin has an established efficacy and safety profile in the treatment of respiratory tract infections.

OBJECTIVE:

The purpose of this study was to compare the clinical and bacteriologic efficacy and tolerability of clarithromycin extended-release and immediate-release formulations in patients with acute exacerbation of chronic bronchitis (AECB).

METHODS:

In a phase III, randomized, double-blind, parallel-group, multicenter study. patients aged > or =12 years with signs and symptoms of AECB and a productive cough with purulent sputum received treatment with extended-release (two 500-mg tablets once daily) or immediate-release (one 500-mg tablet twice daily) clarithromycin for 7 days. Assessments were performed before treatment, within 48 hours after treatment, and at the test-of-cure visit (study days 19-21). Patients who took > or =1 dose of study drug were included in the safety analysis.

RESULTS:

Of 620 patients randomized and treated, 182 were clinically and bacteriologically assessable (100 in the extended-release group and 82 in the immediate-release group). Treatment groups were well matched with respect to demographic characteristics and medical and social history. At the test-of-cure visit, 83% (83/100) of patients in the extended-release and 82% (67/82) of patients in the immediate-release group achieved clinical cure; 86% (85/99) and 85% (70/82), respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were 86% (100/116) in the extended-release group and 88% (86/98) in the immediate-release group. The most frequently reported adverse events were diarrhea (6% in extended-release group vs 4% in immediate-release group; no significant difference), taste alterations (4% in each group), and nausea (3% in each group); no clinically meaningful changes in laboratory values or vital signs, as assessed by the investigator, were observed.

CONCLUSION:

This study suggests that clarithromycin extended-release and immediate-release formulations have equivalent clinical and bacteriologic efficacy and tolerability in patients with AECB.

• Authors: J L Adler, W Jannetti, D Schneider, J Zhang, R Palmer, G Notario
• Journal: Clinical therapeutics (Clin Ther) Vol. 22 Issue 12 Pg. 1410-20 (Dec 2000) ISSN: 0149-2918 [Print] United States
• PMID: 11192133 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Delayed-Action Preparations
• Clarithromycin

Topics

• Acute Disease
• Adult
• Aged
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Bronchitis (drug therapy, physiopathology)
• Chronic Disease
• Clarithromycin (administration & dosage, therapeutic use)
• Delayed-Action Preparations
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Patient Compliance