Investigators: Prof Stephen Stick, Prof Harm A W M Tiddens, Yuxin Chen, Eleni-Rosalina Andrinopoulou, Prof Stephanie D Davis, Prof Margaret Rosenfeld, Prof Felix Ratjen, Prof Richard A Kronmal, Karen D Hinckley Stukovsky, Alison Dasiewicz, and the SHIP-CT Study Group.
Partners: The SHIP CT clinical trial as sponsored by The Kids Research Institute Australia and run in partnership with Erasmus Medical Centre in Rotterdam, in the Netherlands.
Project description:
Cystic fibrosis (CF) lung disease is characterised by thick mucous secretions, chronic airway infection and inflammation. Structural lung disease has already developed in a large population of children with CF by the age of 3-6 years and has a negative effect on clinical outcomes and quality of life. Effective and affordable therapies are needed to prevent or slow development of structural lung disease in children under 6 years of age.
Previous research studies have shown that inhaled hypertonic saline had a positive effect on the lung clearance index as a lung function measure in children under six years of age with CF. However, it remained unclear whether the improvement in the lung clearance index also reflects improvement in structural lung disease.
SHIP-CT, led by Professor Stephen Stick, Director of the Wal-yan Respiratory Research Centre at The Kids, is a unique study in preschool-aged children (from 3-6 years of age) with CF using images of the lung from chest CT scans as the main outcome measure. We showed that treatment with inhaled hypertonic saline, twice daily for 48 weeks, resulted in less structural lung damage compared with children in the isotonic saline group. In addition SHIP-CT combined structural lung disease outcomes and lung function outcomes to improve our understanding of the relationship between structural and functional outcomes in this younger age group.
The SHIP-CT study showed that hypertonic saline is a safe, cheap, and effective therapeutic option to reduce structural lung damage in clinically vulnerable children aged 3-6 years.
Our findings from the SHIP-CT study were published in high-impact medical journal The Lancet Respiratory Medicine in 2022. Another clinical trial co-led by Professor Stephen Stick looked at the effects common antibiotic azithromycin had on structural lung disease from diagnosis until 3 years of age. The study, called COMBAT CF, found treatment with azithromycin had significant positive effects on health outcomes in young children with CF. You can find out more about the COMBAT CF study here.
This important work would not have been possible without the families who took part in the study. We thank them for their time, participation, and significant contribution to CF research.
External collaborators:
- Prof Harm A W M Tiddens, Erasmus University Medical Centre, Rotterdam
- Margaret Rosenfeld, Seattle Children’s Hospital, Seattle
- Stephanie Davis, Indiana University, Indianapolis
- Felix Ratjen, The Hospital for Sick Children, Toronto
Funders: The Cystic Fibrosis Foundation