None listed
Conditions
Brief summary
The purpose of the study is to assess the efficacy of an oral antibiotic (Azithromycin) and an inhaled mucus-clearance agent (nebulised salt water, known as hypertonic saline) in people with bronchiectasis that is not due to cystic fibrosis. The interventions will be administered over a 6-month period. The investigators hypothesise that each intervention will improve the quality of life of people with bronchiectasis by reducing the severity of the chronic lung infection.
Interventions
Six month treatment of daily 250mg oral azithromycin; six month treatment of twice daily 4mL
nebulised 7% saline (with 0.25mg/mL quinine sulphate)
NOTE
This is a two-way factorial study (i.e. four groups in total:
1. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
2. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate);
3. Six month treatment w
Six month treatment of daily 250mg oral azithromycin; six month treatment of twice daily 4mL nebulised 7% saline (with 0.25mg/mL quinine sulphate) NOTE This is a two-way factorial study (i.e. four groups in total: 1. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate); 2. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate); 3. Six month treatment with daily 40mg lactose and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate); 4. Six month treatment with daily 40mg lactose and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate), with participants being allocated to one group for the entire 6-month intervention period.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed