Clinical trial NCT00360464: A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The primary endpoint is investigator's clinical efficacy at Day 8.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Hitachinaka
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Kasama
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Moriya
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Toride
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Pfizer Investigational Site
state: Kangawa
city: Kami-gun
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Shigesato-cho, Nagasaki
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Shindoori, Niigata-shi
country: Japan
facility: Pfizer Investigational Site
state: Niigata
city: Katano
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Akiruno
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chofu
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chofu
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kodaira
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Yonezawa
country: Japan
facility: Pfizer Investigational Site
state: Yamagata
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: