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

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

Tracking Information

• First Submitted Date: August 3, 2006
• First Posted Date: August 4, 2006
• Last Update Posted Date: April 21, 2011
• Study Start Date: October 2006
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 23, 2007): The primary endpoint is investigator's clinical efficacy at Day 8.
• Original Primary Outcome Measures (submitted: August 3, 2006): The primary endpoint is Investigator's Clinical efficacy at Day 8.
• Current Secondary Outcome Measures (submitted: June 13, 2008): 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.

Original Secondary Outcome Measures (submitted: August 3, 2006)

• 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 Laboratory data

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Bronchitis
• Intervention: Drug: Azithromycin SR
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2008): 64
• Original Enrollment (submitted: August 3, 2006): 60
• Actual Study Completion Date: June 2007
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00360464
• Other Study ID Numbers: A0661175
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2011