A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

Pfizer

Status and phase: Completed; Phase 3

Conditions: Acute Bronchitis

Treatments: Drug: Azithromycin SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00360464

A0661175

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)