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

This study has been completed.

First Received: August 3, 2006 Last Updated: June 13, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00360464

Purpose

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.

Condition	Intervention	Phase
Acute Bronchitis	Drug: Azithromycin SR	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	64
Study Start Date:	September 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360464

Locations

Japan, Ibaraki
Pfizer Investigational Site
Toride, Ibaraki, Japan, 302-0005
Pfizer Investigational Site
Moriya, Ibaraki, Japan, 302-0118
Pfizer Investigational Site
Kasama, Ibaraki, Japan, 309-1793
Pfizer Investigational Site
Tsuchiura, Ibaraki, Japan, 300-0053
Pfizer Investigational Site
Hitachinaka, Ibaraki, Japan, 312-0057
Japan, Kanagawa
Pfizer Investigational Site
Yokohama, Kanagawa, Japan, 232-0021
Japan, Kangawa
Pfizer Investigational Site
Yokosuka, Kangawa, Japan, 239-0821
Japan, Miyagi
Pfizer Investigational Site
Kami-gun, Miyagi, Japan, 981-4321
Japan, Nagasaki
Pfizer Investigational Site
Shigesato-cho, Nagasaki, Nagasaki, Japan, 852-8511
Japan, Niigata
Pfizer Investigational Site
Shindoori, Niigata-shi, Niigata, Japan, 950-2087
Japan, Osaka
Pfizer Investigational Site
Katano, Osaka, Japan, 576-0016
Japan, Tokyo
Pfizer Investigational Site
Shinagawa, Tokyo, Japan, 140-0011
Pfizer Investigational Site
Akiruno, Tokyo, Japan, 190-0163
Pfizer Investigational Site
Chofu, Tokyo, Japan, 182-0006
Pfizer Investigational Site
Kodaira, Tokyo, Japan, 187-0042
Pfizer Investigational Site
Setagaya, Tokyo, Japan, 158-0095
Pfizer Investigational Site
Chofu, Tokyo, Japan, 182-0022
Pfizer Investigational Site
Nakano, Tokyo, Japan, 164-0012
Japan, Yamagata
Pfizer Investigational Site
Yonezawa, Yamagata, Japan, 992-0045

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661175
Study First Received:	August 3, 2006
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00360464 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Acute Disease
Anti-Infective Agents
Disease Attributes
Bronchial Diseases
Respiration Disorders
Pharmacologic Actions
Anti-Bacterial Agents
Lung Diseases, Obstructive

Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Azithromycin
Bronchitis

ClinicalTrials.gov processed this record on February 08, 2010