title: 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.
  
  
  CONCLUSIONS
  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.affiliation: Vanderbilt Asthma Sinus Allergy Program, Nashville, Tennessee 37203, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Murray
authors.forename: E
authors.initials: E
authors.lastname: Solomon
authors.forename: D
authors.initials: D
authors.lastname: McCluskey
authors.forename: J
authors.initials: J
authors.lastname: Zhang
authors.forename: R
authors.initials: R
authors.lastname: Palmer
authors.forename: G
authors.initials: G
authors.lastname: Notario
mesh_terms: D000208:Acute Disease; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D015523:Maxillary Sinusitis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008875:Middle Aged; D010349:Patient Compliance; D010919:Placebos; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos; D017291:Clarithromycin