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

Primary Purpose

Acute Bronchitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azithromycin SR
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
August 3, 2006
Last Updated
April 20, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00360464
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin SR
Primary Outcome Measure Information:
Title
The primary endpoint is investigator's clinical efficacy at Day 8.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hitachinaka
State/Province
Ibaraki
ZIP/Postal Code
312-0057
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriya
State/Province
Ibaraki
ZIP/Postal Code
302-0118
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toride
State/Province
Ibaraki
ZIP/Postal Code
302-0005
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0021
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokosuka
State/Province
Kangawa
ZIP/Postal Code
239-0821
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kami-gun
State/Province
Miyagi
ZIP/Postal Code
981-4321
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shigesato-cho, Nagasaki
State/Province
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shindoori, Niigata-shi
State/Province
Niigata
ZIP/Postal Code
950-2087
Country
Japan
Facility Name
Pfizer Investigational Site
City
Katano
State/Province
Osaka
ZIP/Postal Code
576-0016
Country
Japan
Facility Name
Pfizer Investigational Site
City
Akiruno
State/Province
Tokyo
ZIP/Postal Code
190-0163
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chofu
State/Province
Tokyo
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chofu
State/Province
Tokyo
ZIP/Postal Code
182-0022
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-0042
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakano
State/Province
Tokyo
ZIP/Postal Code
164-0012
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
158-0095
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
140-0011
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yonezawa
State/Province
Yamagata
ZIP/Postal Code
992-0045
Country
Japan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661175&StudyName=A%20Trial%20Of%20Azithromycin%20SR%20For%20The%20Treatment%20Of%20Acute%20Bronchitis%20And%20Secondary%20Infection%20Of%20Chronic%20Respiratory%20Diseases
Description
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A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

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