A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases In Japan Adults

Pfizer1 site in 1 country64 target enrollmentOctober 2006

ConditionsAcute Bronchitis

DrugsAzithromycin SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Acute Bronchitis
Sponsor: Pfizer
Enrollment: 64
Locations: 1
Primary Endpoint: The primary endpoint is investigator's clinical efficacy at Day 8.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

June 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997).

Exclusion Criteria

•Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Outcomes

Primary Outcomes

The primary endpoint is investigator's clinical efficacy at Day 8.

Secondary Outcomes

Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 15 and 29), and the tendency toward clinical improvement (at Day 4); Bacteriological efficacy (at Day 4, 8, 15 and 29); Safety Endpoints: Adverse events and safety lab data.