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CompletedNCT00360464Updated Apr 21, 2011

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

A Phase 3 interventional study of Azithromycin SR in Acute Bronchitis, sponsored by Pfizer. Completed at 19 sites in Japan. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-04-21.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 64 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Interventions

  • DrugAzithromycin SR
06

What researchers measure

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.

07

Study locations

19 sites
  • Pfizer Investigational Site
    Hitachinaka, Ibaraki 312-0057, Japan
  • Pfizer Investigational Site
    Kasama, Ibaraki 309-1793, Japan
  • Pfizer Investigational Site
    Moriya, Ibaraki 302-0118, Japan
  • Pfizer Investigational Site
    Toride, Ibaraki 302-0005, Japan
  • Pfizer Investigational Site
    Tsuchiura, Ibaraki 300-0053, Japan
  • Pfizer Investigational Site
    Yokohama, Kanagawa 232-0021, Japan
  • Pfizer Investigational Site
    Yokosuka, Kangawa 239-0821, Japan
  • Pfizer Investigational Site
    Kami-gun, Miyagi 981-4321, Japan
  • Pfizer Investigational Site
    Shigesato-cho, Nagasaki, Nagasaki 852-8511, Japan
  • Pfizer Investigational Site
    Shindoori, Niigata-shi, Niigata 950-2087, Japan
  • Pfizer Investigational Site
    Katano, Osaka 576-0016, Japan
  • Pfizer Investigational Site
    Akiruno, Tokyo 190-0163, Japan
  • Pfizer Investigational Site
    Chofu, Tokyo 182-0006, Japan
  • Pfizer Investigational Site
    Chofu, Tokyo 182-0022, Japan
  • Pfizer Investigational Site
    Kodaira, Tokyo 187-0042, Japan
  • Pfizer Investigational Site
    Nakano, Tokyo 164-0012, Japan
  • Pfizer Investigational Site
    Setagaya, Tokyo 158-0095, Japan
  • Pfizer Investigational Site
    Shinagawa, Tokyo 140-0011, Japan
  • Pfizer Investigational Site
    Yonezawa, Yamagata 992-0045, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00360464
Lead sponsor
Pfizer
First posted
Aug 4, 2006
Start date
Oct 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Apr 21, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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