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Clinical Trials/ACTRN12611001199909
ACTRN12611001199909RecruitingPhase 3

The effect of azithromycin and hypertonic saline on quality of life, lung function and exercise capacity in adults with non-cystic fibrosis bronchiectasis

Sydney Local Health District0 sites130 target enrollmentStarted: November 22, 2011Last updated:

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
130

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

Inclusion Criteria

  • Non-cystic fibrosis bronchiectasis (defined as chronic cough and sputum production with at least two lobes involved on HRCT);
  • Aged at least 18 years;
  • FEV1 within 10% of the best outpatient value during the previous six months;
  • At least two weeks since antibiotics for a respiratory exacerbation

Exclusion Criteria

  • Inability to provide informed consent;
  • Known allergy to macrolide therapy or quinine sulphate;
  • Thrombocytopaenia;
  • Immune thrombocytopaenia purpura (ITP);
  • Hypertonic saline or mannitol therapy in the previous two weeks;
  • Macrolide therapy in the previous four weeks;
  • Use of drugs contra-indicated by macrolide therapy;
  • FEV1<30% predicted;
  • Current smoking;
  • Unstable coronary heart disease;
  • Immunodeficiency;
  • Renal failure;
  • Severe liver disease;
  • Cerebrovascular disease;
  • Previous organ transplant;
  • Current or intended pregnancy in the following seven months;
  • Participation in another clinical trial in the previous 30 days or intended in the following seven months;
  • Non-tuberculous mycobacterium identified in sputum culture

Investigators

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