Efficacy of Azithromycin in Treatment of Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: Azithromycin; Placebo for Azithromycin
Intervention description: Azithromycin (C38H72N2O12 MW 749) is a 15-membered azalide, a subclass of macrolide antibiotics; In Part One of the study participants will be randomised to receive 12 weeks of either placebo or azithromycin in a 1:1 ratio in a double-blinded fashion. After 12 weeks, in Part Two of the study, all participants will receive placebo in a double-blinded fashion for an additional 12 weeks.
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Azithromycin; Bronchiectasis; Macrolide; Inflammation; Pulmonary

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.
    

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