CRCAH project no: IKCD188
Menzies School of Health Research
Peter Morris, Patricia Valery and Anne Chang
Gabrielle McCallum, Nursing Study Coordinator
- National Health & Medical Research Council
- Telstra Foundation
- Queensland Institute of Medical Research
- Royal Children's Hospital, Brisbane
- University of Sydney
- CDC, Alaska
- Starship Children's Hospital, NZ
This project is endorsed as an in-kind project of the CRCAH.
Aboriginal children in remote Australia have extremely high rates of pneumonia; some get better while others develop bronchiectasis (a chronic suppurative lung disease characterised by chronic wet cough). Chronic wet or moist cough is common among Indigenous children. Bronchiectasis is a severe disease that, once established, affects individuals throughout their life. While this condition was recognised frequently in Australians up to 50 years ago, it is now usually limited to those with cystic fibrosis or immunodeficiency. Unfortunately, bronchiectasis still contributes to the unacceptably high burden of respiratory disease in Aboriginal Australians.
The optimal treatment of bronchiectasis in this population is not known. The similarity of bronchiectasis among Indigenous populations in affluent countries has resulted in this collaborative study of Indigenous children (Aboriginal and Torres Strait Islander and New Zealand Maori or Pacific Islander). The study design is identical in the participating countries.
This study is being carried out internationally in New Zealand, Alaska and Australia. There are two parts to this study, the Observational arm and the Interventional arm. In the Northern Territory we will be visiting communities in Central Australia and the Top End.
Bronchiectasis Observational Study (BOS)
Indigenous children aged between 6 months to 8 years diagnosed with chronic and/or recurrent lung disease or established bronchiectasis will be eligible to participate. For the duration of the study children will be seen clinically at least twice a year by the study paediatrician and twice a year by the study nurse. When children need medical attention for pulmonary exacerbations or other conditions, they will seek usual care the community health clinic or relevant hospital. Children participating in the observational study (BOS) who are found to have “definite bronchiectasis” or “probable bronchiectasis” will also be eligible to participate in the interventional study (BIS).
Bronchiectasis Interventional Study (BIS)
A randomised double-blind placebo controlled trial comparing maintenance antibiotic treatment (azithromycin 30 mg/kg once/week) versus placebo in children aged 12 months to 8 years diagnosed with ‘definite bronchiectasis’ (confirmed clinically or with a High Resolution CT scan – HRCT) OR a clinical diagnosis of CSLD after appropriate investigations are completed by the study Paediatrician are eligible. These arms of the study will examine the effectiveness and safety of maintenance azithromycin treatment when used to prevent exacerbations of bronchiectasis in Indigenous children. After informed consent is obtained, the child will be randomly allocated to one of the two treatment groups. If the child has a pulmonary exacerbation or LRTI, they will receive their standard treatment before beginning the study medicine.
The aims of this project are to:
(1) Define the natural history of chronic moist cough and bronchiectasis
(2) Identify the risk factors associated with progression from early disease to bronchiectasis;
(3) Evaluate maintenance antibiotic treatment in the prevention of pulmonary exacerbations;
(4) Assess the impact of antibiotic treatment on antibiotic resistance.
(1) Indigenous children with chronic moist cough plus CXR abnormalities are more likely to develop bronchiectasis than children without CXR abnormailities;
(2) Maintenance antibiotic therapy with azithromycin can reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis and improve health outcomes;
(3) Maintence antibiotic therapy is not associated with unacceptable rates of antibiotic resistance.
Children will be given better follow up and treatment for their cough or bronchiectasis. The information will help doctors know how the disease progresses and how to give the best treatment in the future. However we cannot guarantee that an individual child will receive any benefit from the study medicine.
The study will improve access of remote and rural communities to specialist paediatric respiratory education and clinical services (there is a limited paediatric respiratory service to the region). For children involved in the study, the most important benefit is that a greater proportion will receive close follow up and prompt treatment of pulmonary exacerbations. Aboriginal Health Workers involved in the study will receive support and informal training in the management of the respiratory illness in rural and remote communities. In the longer term, these results will be transferable to other Aboriginal communities.
Wider community (national and international)
Aboriginal and Torres Straight Island children and other Indigenous groups overseas continue to have unacceptably high rates of chronic respiratory diseases. If effective, a treatment regime which is simple to administer (e.g. an antibiotic that is taken orally once a week) could substantially improve the prognosis of Indigenous children with bronchiectasis.
Summary of Project Outcomes
We have 72 Aboriginal and 37 Alaska Native children with CSLD or bronchiectasis included in the observational study to date (April 2009). In late 2008, we commenced the interventional arm of the study (BIS) in Australia and New Zealand. Australia have enrolled 19 children to date and 14 from New Zealand.