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

Condition(s) targeted: Bronchitis; Respiratory Tract Diseases

Intervention: Azithromycin SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome:

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 Laboratory

data

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Pfizer Investigational Site, Toride, Ibaraki 302-0005, Japan

Pfizer Investigational Site, Moriya, Ibaraki 302-0118, Japan

Pfizer Investigational Site, Kasama, Ibaraki 309-1793, Japan

Pfizer Investigational Site, Tsuchiura, Ibaraki 300-0053, Japan

Pfizer Investigational Site, Hitachinaka, Ibaraki 312-0057, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 232-0021, Japan

Pfizer Investigational Site, Yokosuka, Kangawa 239-0821, Japan

Pfizer Investigational Site, Kami-gun, Miyagi 981-4321, Japan

Pfizer Investigational Site, Shigesato-cho, Nagasaki, Nagasaki 852-8511, Japan

Pfizer Investigational Site, Shindoori, Niigata-shi, Niigata 950-2087, Japan

Pfizer Investigational Site, Katano, Osaka 576-0016, Japan

Pfizer Investigational Site, Shinagawa, Tokyo 140-0011, Japan

Pfizer Investigational Site, Akiruno, Tokyo 190-0163, Japan

Pfizer Investigational Site, Chofu, Tokyo 182-0006, Japan

Pfizer Investigational Site, Kodaira, Tokyo 187-0042, Japan

Pfizer Investigational Site, Setagaya, Tokyo 158-0095, Japan

Pfizer Investigational Site, Chofu, Tokyo 182-0022, Japan

Pfizer Investigational Site, Nakano, Tokyo 164-0012, Japan

Pfizer Investigational Site, Yonezawa, Yamagata 992-0045, Japan

To obtain contact information for a study center near you, click here.

Starting date: September 2006
Last updated: October 24, 2007