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A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

Last updated on December 12, 2019

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Study Location
Pfizer Investigational Site
Anzin, , 59410 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Bronchitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
36-74 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Inclusion Criteria:

- Outpatients presenting with an exacerbation of chronic bronchitis including: chronic
bronchitis with obstructive respiratory disorders documented by a forced expiratory
volume of below 80% and higher than 35% of the theoretical value, within the previous
12 months; and thought to be of infectious origin

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Exclusion Criteria:

- Patient not presenting with the associated signs of an exacerbation

- Patient presenting with clinical signs suggestive of pneumonopathy at inclusion

- Patient requiring hospitalisation in intensive care

NCT00649831
Pfizer
Completed
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

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Descriptive Information
Brief Title  ICMJE A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis
Official Title  ICMJE Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis
Brief Summary This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchitis, Chronic
Intervention  ICMJE
  • Drug: Amoxicillin/clavulinic acid
    amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
  • Drug: Azithromycin
    Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
Study Arms  ICMJE
  • Active Comparator: Group 2
    Intervention: Drug: Amoxicillin/clavulinic acid
  • Active Comparator: Group 1
    Intervention: Drug: Azithromycin
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 27, 2008)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria:

  • Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin

Exclusion Criteria:

Exclusion Criteria:

  • Patient not presenting with the associated signs of an exacerbation
  • Patient presenting with clinical signs suggestive of pneumonopathy at inclusion
  • Patient requiring hospitalisation in intensive care
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649831
Other Study ID Numbers  ICMJE A0661045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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