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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.
Clin Ther. 2000 Dec; 22(12):1410-20.CT

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+Show Affiliations

Clinicos Clinical Research, Colorado Springs, Colorado 80904, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11192133

Citation

Adler, J L., et al. "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." Clinical Therapeutics, vol. 22, no. 12, 2000, pp. 1410-20.
Adler JL, Jannetti W, Schneider D, et al. 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. Clin Ther. 2000;22(12):1410-20.
Adler, J. L., Jannetti, W., Schneider, D., Zhang, J., Palmer, R., & Notario, G. (2000). 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. Clinical Therapeutics, 22(12), 1410-20.
Adler JL, et al. 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. Clin Ther. 2000;22(12):1410-20. PubMed PMID: 11192133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Adler,J L, AU - Jannetti,W, AU - Schneider,D, AU - Zhang,J, AU - Palmer,R, AU - Notario,G, PY - 2001/2/24/pubmed PY - 2001/3/27/medline PY - 2001/2/24/entrez SP - 1410 EP - 20 JF - Clinical therapeutics JO - Clin Ther VL - 22 IS - 12 N2 - 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. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/11192133/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(00)83040-4 DB - PRIME DP - Unbound Medicine ER -