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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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ClinicalTrials.gov Identifier: NCT00360464
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : April 21, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: Azithromycin SR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. The primary endpoint is investigator's clinical efficacy at Day 8.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360464

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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, 182-0006
Pfizer Investigational Site
Chofu, Tokyo, Japan, 182-0022
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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00360464    
Other Study ID Numbers: A0661175
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: April 21, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Acute Disease
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents