CHEP - Clinical trials
Early Life Origins of CF Disease (ELO) Study
Children with Cystic Fibrosis (CF) are born with structurally normal lungs but as they grow older, they are at risk of repeated respiratory infections that can damage the lungs. Despite the advances in treatment and the overall better outcomes for children with CF, older children and adults still lose lung function. There is growing concern that CF lung disease begins very early in life and there has been much focus recently on trying to better understand early CF lung disease.
The Early Life Origins of CF Disease (ELO) Study is an observational study (no drug or therapy interventions) that is being conducted at The Queensland Children’s and Prince Charles Hospitals. Patients will be followed for three years and information relating to clinic and annual review visits will be collated. Our specific aims are (i) to better understand the mechanisms of early disease onset and how CF lung disease progresses throughout a patients’ life and (ii) improve/develop appropriate clinical outcome measures (lung function testing, biomarkers, imaging techniques) to improve CF management.
Contact: CLEAR@uq.edu.au.
Prevention with OM-85 of wheezing exacerbation recurrence (POWER) trial: double-blind RCT of immunomodulation in wheezing children.
Wheezing, asthma attacks and respiratory infections are a major problem for some children and they are a risk factor for future wheezing and asthma attacks as well as worsening asthma disease. The common cold virus, human rhinovirus (RV), is an important cause of wheezing and asthma attacks in children. The purpose of this study is to see if we can understand how a treatment for respiratory illnesses and asthma works in children and whether it can prevent future wheezing, asthma attacks and respiratory infections. This treatment is called OM-85 (or Bronchovaxom).
This research study has been initiated by the study doctors, Professors Peter Le Souëf and Peter Sly and is being conducted by doctors and researchers from the University of Western Australia, School of Medicine and Perth Children’s Hospital as well as the University of Queensland, Centre for Children’s Health Research and the Queensland Children’s Hospital.
This study is being funded by the National Health and Medical Research Council. The company providing the OM-85 treatment is ViforPharma. The University of Western Australia is the sponsor of the study.
Contact: Wheezy@uq.edu.au
Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85
The purpose of this study is to see if development of acute severe respiratory infections (ARI) in Health Care Workers (HCW) necessitating removal from the workforce can be prevented.
The University of Queensland is conducting a research study in collaboration with the Queensland Children’s Hospital, Metro South and Metro North. The study aims to reduce the proportion of HCW contracting an ARI necessitating workforce removal by treating with OM-85 (Broncho-Vaxom), an immunostimulant that has been used in 65 countries for over 30 years. The drug works by priming the immune system so that the body can respond quickly to infections.
Evidence from numerous trials has demonstrated that OM85 treatment during periods of high infection risk can reduce the frequency of symptomatic ARI. The mechanism-of-action appears to involve reduction in susceptibility to upper respiratory infection and attenuation of the intensity of inflammation-associated symptoms that accompany infection spread to the lower airways.
Eligible participants will be treated with study medication (OM85) as a participant of either group 1([waitlist control, delayed treatment group] - treatment commences at three months, visit 2) or group 2 ([initial treatment group] -treatment commences at visit 1). There will be a 50:50 chance of allocation to either group.
Contact: COVIDRASP@uq.edu.au
Combat CF (closed)
This is a phase 3 multi-centre randomized placebo-controlled study of azithromycin in the primary prevention of radiologically-defined bronchiectasis in infants with cystic fibrosis. The purpose of this study is to see if we can prevent or delay the onset of lung disease in children with Cystic Fibrosis by giving them Azithromycin from when they are very young.
The study is funded by Cystic Fibrosis Foundation Therapeutics in the US and the sponsor for the study is Telethon Kids Institute. There are eight centres across Australia and New Zealand (Perth, Brisbane, Melbourne, Sydney, Adelaide and Auckland). Total of 130 participants have to be recruited for the study. The recruitment is still in progress for the study.
The children diagnosed with cystic fibrosis by New Born Screening can be enrolled in the study by six months of age. They will receive azithromycin or placebo thrice a week till the age of 3 years. There are 14 visits to the hospital with bronchoscopy at the first visit and then at the age of 1 ad 3 years and the CT scans are done at the age of 1 and 3 years.
For enquiries about the study please contact the clinical team on clear@uq.edu.au
Prevention of Asthma in Children (closed)
(OM-85 in Prevention of Asthma in Children)
This is a phase 2, single-centre, double blind, randomised, placebo-controlled, study testing the primary prevention of persistent asthma in high risk children by protection against acute respiratory infections during early childhood using OM-85. Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The purpose of this study is to see if we can prevent asthma by stopping some of the events that happen early in life which may cause asthma. These are events like respiratory tract infections (colds and flu), wheezing and sensitisation to allergens.
OM-85 is an immune-stimulant which primes the immune system so that the body can respond quickly to infections and reduce damage to the lungs to prevent asthma from developing. OM-85 is a capsule and powder from capsule is dissolved in water and given to the child. The child receives OM-85 or placebo as five blocks of 10 days treatment plus 20 days no treatment for two winters and then they are followed up in the third year without any treatment.
This study is funded by the National Health and Medical Research Council and is being conducted at the Lady Cilento Children’s Hospital in Brisbane. Child Health Research Centre at The University of Queensland is the sponsor for the study. The recruitment for this study has been completed.
OMPAC final report is now available.