Efficacy of Azithromycin in Treatment of Bronchiectasis

Brief Title

Efficacy of Azithromycin in Treatment of Bronchiectasis

Official Title

Efficacy of Azithromycin in Treatment of Bronchiectasis

Brief Summary

      Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the
      airways. Only a small number of clinical studies have been conducted investigating the use of
      macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to
      determine the efficacy of 12 weeks treatment with azithromycin in adult patients with
      non-cystic fibrosis bronchiectasis.
    

Detailed Description

      Previous studies of various macrolides with small sample sizes have reported some benefit
      with the reduction of sputum volume in bronchiectasis patients. However, macrolide therapy
      could not yet be confidently used to treat bronchiectasis, given the diffuse nature of these
      findings. These studies have had a wide range of hypotheses, and have not necessarily focused
      on the anti-inflammatory effects of macrolides. Furthermore, these studies are few in number,
      and not all have been placebo-controlled or double-blinded. This, combined with the small
      sample sizes used, limits the reliability of these results. This study aims to expand on
      these limited published findings by investigating a larger sample population with different
      endpoints. Sputum volume and quality of life have been selected as important variables to aid
      in assessing efficacy.

      This study aims to be independent of previous studies in a number of ways. This is the only
      study of bronchiectasis patients to formally investigate quality of life after treatment with
      a macrolide, and the potential carryover effect of azithromycin therapy. This study will also
      expand on the findings of previous studies of macrolides in bronchiectasis by incorporating a
      larger sample size into the trial.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

24 Hour Sputum Volume

Secondary Outcome

 Health Status: St George's Respiratory Questionnaire Score

Condition

Bronchiectasis

Intervention

Azithromycin

Study Arms / Comparison Groups

 Azithromycin and Placebo for Azithromycin

Description:  Patients randomised to the treatment arm are to receive 1000 mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once weekly for another 12 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

78

Start Date

November 2011

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Have provided written informed consent to participate in the study in accordance with
             the local ethics committee regulations

          -  Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have
             chronic sputum production, defined as a greater than 45 mililitres volume produced in
             the 1 week prior to study entry.

          -  Be able to perform reproducible spirometry

          -  Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by
             the absence of the following: respiratory exacerbations requiring hospitalisation,
             change in cough and/or sputum production, new or increased hemoptysis, more than 10%
             weight loss, use of additional antibiotic courses

        Exclusion Criteria:

          -  Subjects will be excluded if one or more of the following criteria occur. The subject:
             Is an investigator, or an immediate family member of an investigator

          -  Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a
             sweat test result more than 60mmol/L

          -  Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory
             exacerbation requiring hospitalisation or additional course of antibiotics in the 6
             weeks prior to study entry

          -  Has been prescribed or used oral steroids on any occasion for the 3 months prior to
             study entry.

          -  Has been using mucolytic agents on any occasion for the 2 months prior to study entry
             Has active tuberculosis

          -  Has an active malignancy, including melanoma (other skin carcinomas excluded)

          -  Has a history of significant liver disease or insufficiency Has a significant history
             of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or
             allergy to macrolides

          -  Has been participating in another interventional drug study in the 3 months prior to
             enrolment into this study
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

ALBERT IRUTHIARAJ ANTHONY, MBBS, , 

Location Countries

Malaysia

Location Countries

Malaysia

NCT ID

NCT02107274

Organization ID

NMRR-09-1075-5016

Responsible Party

Principal Investigator

Study Sponsor

Penang Hospital, Malaysia

Study Sponsor

ALBERT IRUTHIARAJ ANTHONY, MBBS, Principal Investigator, Penang Hospital, Malaysia

Verification Date

July 2014