NCT00360464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 21, 2011

Status Verified

April 1, 2011

Enrollment Period

8 months

First QC Date

August 3, 2006

Last Update Submit

April 20, 2011

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is investigator's clinical efficacy at Day 8.

Secondary Outcomes (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.

Interventions

Azithromycin SRDRUG

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pfizer Investigational Site

Hitachi-Naka, Ibaraki, 312-0057, Japan

Location

Pfizer Investigational Site

Kasama, Ibaraki, 309-1793, Japan

Location

Pfizer Investigational Site

Moriya, Ibaraki, 302-0118, Japan

Location

Pfizer Investigational Site

Toride, Ibaraki, 302-0005, Japan

Location

Pfizer Investigational Site

Tsuchiura, Ibaraki, 300-0053, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, 232-0021, Japan

Location

Pfizer Investigational Site

Yokosuka, Kangawa, 239-0821, Japan

Location

Pfizer Investigational Site

Kami-gun, Miyagi, 981-4321, Japan

Location

Pfizer Investigational Site

Shigesato-cho, Nagasaki, Nagasaki, 852-8511, Japan

Location

Pfizer Investigational Site

Shindoori, Niigata-shi, Niigata, 950-2087, Japan

Location

Pfizer Investigational Site

Katano, Osaka, 576-0016, Japan

Location

Pfizer Investigational Site

Akiruno, Tokyo, 190-0163, Japan

Location

Pfizer Investigational Site

Chōfu, Tokyo, 182-0006, Japan

Location

Pfizer Investigational Site

Chōfu, Tokyo, 182-0022, Japan

Location

Pfizer Investigational Site

Kodaira, Tokyo, 187-0042, Japan

Location

Pfizer Investigational Site

Nakano City, Tokyo, 164-0012, Japan

Location

Pfizer Investigational Site

Setagaya City, Tokyo, 158-0095, Japan

Location

Pfizer Investigational Site

Shinagawa, Tokyo, 140-0011, Japan

Location

Pfizer Investigational Site

Yonezawa, Yamagata, 992-0045, Japan

Location

Related Links

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 4, 2006

Study Start

October 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

April 21, 2011

Record last verified: 2011-04

Locations

JP(19)