ovel interventions for the diverse population of Australians with bronchiectasis

Phase 3

Recruiting

• Conditions: on-cystic fibrosis bronchiectasis; Non-cystic fibrosis bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12611001199909
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 130

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;
Carcinoma;
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life, measured with the St George Respiratory Questionnaire[Baseline (Month 0)<br>Month 1<br>Month 3<br>Month 6<br>Month 7 (one month after ceasing trial medications)]