Trial record 5 of 136 for:    Bronchitis: Clinical Trials

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360464
First received: August 3, 2006
Last updated: April 20, 2011
Last verified: April 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Pfizer Investigational Site
Hitachinaka, Ibaraki, Japan, 312-0057
Pfizer Investigational Site
Kasama, Ibaraki, Japan, 309-1793
Pfizer Investigational Site
Moriya, Ibaraki, Japan, 302-0118
Pfizer Investigational Site
Toride, Ibaraki, Japan, 302-0005
Pfizer Investigational Site
Tsuchiura, Ibaraki, Japan, 300-0053
Pfizer Investigational Site
Yokohama, Kanagawa, Japan, 232-0021
Pfizer Investigational Site
Yokosuka, Kangawa, Japan, 239-0821
Pfizer Investigational Site
Kami-gun, Miyagi, Japan, 981-4321
Pfizer Investigational Site
Shigesato-cho, Nagasaki, Nagasaki, Japan, 852-8511
Pfizer Investigational Site
Shindoori, Niigata-shi, Niigata, Japan, 950-2087
Pfizer Investigational Site
Katano, Osaka, Japan, 576-0016
Pfizer Investigational Site
Akiruno, Tokyo, Japan, 190-0163
Pfizer Investigational Site
Chofu, Tokyo, Japan, 182-0022
Pfizer Investigational Site
Chofu, Tokyo, Japan, 182-0006
Pfizer Investigational Site
Kodaira, Tokyo, Japan, 187-0042
Pfizer Investigational Site
Nakano, Tokyo, Japan, 164-0012
Pfizer Investigational Site
Setagaya, Tokyo, Japan, 158-0095
Pfizer Investigational Site
Shinagawa, Tokyo, Japan, 140-0011
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00360464     History of Changes
Other Study ID Numbers: A0661175
Study First Received: August 3, 2006
Last Updated: April 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Respiration Disorders
Respiratory Tract Diseases
Coinfection
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Infection
Virus Diseases
Parasitic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014