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CLIMB-CF

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Other

Trial status

Open to recruitment

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Pilot/Feasibility

Full title

Clinical Monitoring and Biomarkers to stratify severity and predict outcomes in children with cystic fibrosis (CLIMB-CF).

Cystic fibrosis affects around 10,000 people in the UK and an estimated > 100,000 worldwide. It is a multisystem condition, with lung disease being the most significant, leading to early infection, inflammation and scarring. Currently, despite huge improvements in clinical care, the median age of death in the UK is just over 30 years. Babies are now diagnosed on newborn screening and are usually asymptomatic, but lung disease begins early. Disease progression is variable and influenced by a number of factors, one of the most important being the frequency of pulmonary exacerbations (PEx), poorly understood periods of increasing symptoms and a fall in lung function; with a quarter of patients experiencing a PEx having permanent loss of lung function as a result. Currently, PEx are detected once fully established; earlier detection, perhaps by monitoring for warning signs in the community, could lead to earlier treatment and improved outcomes. We will aim to recruit all paediatric patients at the Royal Brompton Hospital to look in-depth at their specific characteristics and to look for potential biomarkers in samples collected at home or in clinic to identify a PEx before it's established. A subset will fill in either a web based symptom diary or be given home monitoring equipment and carry out home sample collection over 6 months as part of a multi-centre study. The children will be separated into age bands for analysis (0-2 yrs, 3-5 yrs, 6-11 yrs, 12-17 yrs inclusive) in order to correct for the potentially more risky period of adolescence. The aim of this study is to test the feasibility of home monitoring and sample collection at home or in clinic to identify these PEx without adversely affecting quality of life. We aim to identify the most at risk patients in each age group in order to direct potential interventions.

Trial type

Non-medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

6 Months

Recruitment target
The number of participants who need to be recruited for the trial in the UK

370

Last edited date

15 August 2016

Sponsor

Imperial College London

Sponsor type

Academic

Who can take part?

Top inclusion criteria
  • Cystic fibrosis confirmed by standard criteria
  • Males and females aged 0-17 years (only those aged 2-17 years of age eligible for Smart app and home monitoring arm)
  • Written informed consent obtained from parent or young person aged 16 years or over; age-specific assent will be sought as appropriate from the child
Top exclusion criteria
  • Clinical instability at screening defined by not on any additional antibiotics (excluding routine, long-term treatments) for the previous 2 weeks
  • No increase in symptoms such as change in sputum production/colour, increased wheeze or breathlessness over the previous 2 weeks.
  • No change in regular respiratory treatments over the previous 4 weeks .

CF centres running this trial

Recruiting

Alder Hey Children's NHS Foundation Trust

Address

Alder Hey Hospital Eaton Road West Derby Liverpool Merseyside L12 2AP

Recruitment starts

May 2017

Recruitment ends

February 2018

Contact

Thursfield, Rebecca

Get in touch

Recruiting

Brighton and Sussex University Hospitals NHS Trust

Address

Sussex Cancer Centre Royal Sussex County Hospital Eastern Road Brighton BN2 5BE

Recruitment starts

May 2017

Recruitment ends

December 2017

Contact

Seddon, Paul

Get in touch

Recruiting

Great Ormond Street Hospital

Address

Great Ormond Street London WC1N 3JH

Recruitment starts

September 2017

Recruitment ends

February 2018

Contact

Wallis, Colin

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

January 2017

Recruitment ends

May 2019

Contact

Davies, Jane C

Get in touch
Show all participating centres