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Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of adult patients with acute maxillary sinusitis.
Clin Ther. 2000 Dec; 22(12):1421-32.CT

Abstract

BACKGROUND

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

OBJECTIVE

This study compares the efficacy and tolerability of extended-release and immediate-release formulations of clarithromycin in patients with acute maxillary sinusitis.

METHODS

Fourteen days' treatment with once-daily clarithromycin was compared with the immediate-release, twice-daily formulation in a phase III, randomized, double-blind, parallel-group, multicenter study. Patients aged > or =12 years with signs, symptoms, and a radiologically confirmed diagnosis of acute maxillary sinusitis were eligible. Patients were assessed before treatment, within 48 hours after treatment, on study days 16 to 18, and at the test-of-cure visit on study days 24 to 31. Patients who received > or =1 dose of study drug were included in the safety analysis.

RESULTS

Of 283 patients treated, 245 were included in the efficacy analysis (122 in the extended-release group, 123 in the immediate-release group). Treatment groups were well matched with respect to demographic characteristics and medical condition and history. At the test-of-cure visit, 85% of patients in the clarithromycin extended-release group and 79% in the immediate-release group were deemed clinical cures; 89% and 91% in the extended-release and immediate-release groups, respectively, demonstrated radiographic success. Overall incidences of study drug-related adverse events were similar in the 2 treatment groups (32% in the extended-release group and 28% in the immediate-release group); however, significantly fewer patients receiving extended-release clarithromycin (2/142 11%]), compared with those receiving the immediate-release formulation (10/141 [7%]: P = 0.02) discontinued therapy because of drug-related gastrointestinal symptoms or abnormal taste. No clinically meaningful changes in laboratory values or vital signs were observed during the study.

CONCLUSION

Although the efficacy of the 2 formulations was comparable, once-daily clarithromycin extended-release was better tolerated than the twice-daily immediate-release formulation by patients with acute maxillary sinusitis.

Authors+Show Affiliations

Vanderbilt Asthma Sinus Allergy Program, Nashville, Tennessee 37203, 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11192134

Citation

Murray, J J., et al. "Phase III, Randomized, Double-blind Study of Clarithromycin Extended-release and Immediate-release Formulations in the Treatment of Adult Patients With Acute Maxillary Sinusitis." Clinical Therapeutics, vol. 22, no. 12, 2000, pp. 1421-32.
Murray JJ, Solomon E, McCluskey D, et al. Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of adult patients with acute maxillary sinusitis. Clin Ther. 2000;22(12):1421-32.
Murray, J. J., Solomon, E., McCluskey, 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 adult patients with acute maxillary sinusitis. Clinical Therapeutics, 22(12), 1421-32.
Murray JJ, et al. Phase III, Randomized, Double-blind Study of Clarithromycin Extended-release and Immediate-release Formulations in the Treatment of Adult Patients With Acute Maxillary Sinusitis. Clin Ther. 2000;22(12):1421-32. PubMed PMID: 11192134.
* 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 adult patients with acute maxillary sinusitis. AU - Murray,J J, AU - Solomon,E, AU - McCluskey,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 - 1421 EP - 32 JF - Clinical therapeutics JO - Clin Ther VL - 22 IS - 12 N2 - BACKGROUND: Clarithromycin has an established bacteriologic efficacy and safety profile in the treatment of respiratory tract infections. OBJECTIVE: This study compares the efficacy and tolerability of extended-release and immediate-release formulations of clarithromycin in patients with acute maxillary sinusitis. METHODS: Fourteen days' treatment with once-daily clarithromycin was compared with the immediate-release, twice-daily formulation in a phase III, randomized, double-blind, parallel-group, multicenter study. Patients aged > or =12 years with signs, symptoms, and a radiologically confirmed diagnosis of acute maxillary sinusitis were eligible. Patients were assessed before treatment, within 48 hours after treatment, on study days 16 to 18, and at the test-of-cure visit on study days 24 to 31. Patients who received > or =1 dose of study drug were included in the safety analysis. RESULTS: Of 283 patients treated, 245 were included in the efficacy analysis (122 in the extended-release group, 123 in the immediate-release group). Treatment groups were well matched with respect to demographic characteristics and medical condition and history. At the test-of-cure visit, 85% of patients in the clarithromycin extended-release group and 79% in the immediate-release group were deemed clinical cures; 89% and 91% in the extended-release and immediate-release groups, respectively, demonstrated radiographic success. Overall incidences of study drug-related adverse events were similar in the 2 treatment groups (32% in the extended-release group and 28% in the immediate-release group); however, significantly fewer patients receiving extended-release clarithromycin (2/142 11%]), compared with those receiving the immediate-release formulation (10/141 [7%]: P = 0.02) discontinued therapy because of drug-related gastrointestinal symptoms or abnormal taste. No clinically meaningful changes in laboratory values or vital signs were observed during the study. CONCLUSION: Although the efficacy of the 2 formulations was comparable, once-daily clarithromycin extended-release was better tolerated than the twice-daily immediate-release formulation by patients with acute maxillary sinusitis. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/11192134/Phase_III_randomized_double_blind_study_of_clarithromycin_extended_release_and_immediate_release_formulations_in_the_treatment_of_adult_patients_with_acute_maxillary_sinusitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(00)83041-6 DB - PRIME DP - Unbound Medicine ER -