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

Phase 3

Completed

• Conditions: Acute Bronchitis

• Registration Number: NCT00360464
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-04
• Study Start: 2006-10
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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).

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Exclusion Criteria

• Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Yonezawa, Yamagata, Japan