Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of adult patients with acute maxillary sinusitis.

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: J J Murray, E Solomon, D McCluskey, J Zhang, R Palmer, G Notario
• Journal: Clinical therapeutics (Clin Ther) Vol. 22 Issue 12 Pg. 1421-32 (Dec 2000) ISSN: 0149-2918 [Print] United States
• PMID: 11192134 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Placebos
• Clarithromycin

Topics

• Acute Disease
• Adult
• Anti-Bacterial Agents (administration & dosage, adverse effects, therapeutic use)
• Clarithromycin (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Maxillary Sinusitis (diagnostic imaging, drug therapy)
• Middle Aged
• Patient Compliance
• Placebos
• Radiography
• Treatment Outcome