ASYMPTOMATIC
Summary
A non-inferiority, pragmatic, randomised controlled trial using routinely collected ouitcome data. Children and young people aged 6-15 years, at the time of randomisation, with mild asthma who are prescribed inhaled corticosteroids recruited from general practices across the UK that are part of the Clinical Practice Research Datalink.
Primary Clinical Outcome - Whether in children (aged 6 to 16 years) with mild asthma - symptom driven use of Inhaled Corticosteroid (ICS) is non-inferior to daily maintenance ICS on the risk of asthma attacks requiring Oral Corticosteroid (OCS).
Primary Health Economic Outcome - The cost-effectiveness (incremental cost per quality-adjusted life year, QALY gained) of symptom-driven use of ICS.
For more information please click HERE for the full summary.
Contact the team at mse.lehprimarycareresearch@nhs.net for the study protocol.
Further details can be viewed on the university's website.
Sponsor - European Union Drug Regulating Authorities Clinical Trials Database (Eudra-CT)
Recruitment End Date - 30-09-2024
Type of Study - Recruiting
RSI Points - 400 points
EMIS/CPRD Practices Only!
Practice Involvement
Review IRSP list and screen for eligibility.
GP or delegated clinician to contact parents to discuss the trial via telephone.
Consenting participants.
To confirm eligibility.
Randomise participants.
Study intervention prescription.
Assessment of SAE.
Eligibility Criteria
Inclusion
Aged 6-15 years, at the time of enrolment.
Mild asthma.
At least one relevant (for asthma) prescription of short acting beta agonists (SABA) or inhaled corticosteroids in the last 12 months (including new diagnoses).
Written and informed consent and assent from the participant's parent/legal representatie and participant respectively, and agreement of the parent and participant to comply with the requirements of the trial.
Exclusion
Hospitalised for asthma in the last 12 months.
three or more asthma attacks treated with oral corticosteroids in the last 12 months.
Significant respiratory comorbidity.
Patients prescribed or taking any of the following medications at the time of randomisation: Montelukast, long acting beta - agonist whether in combination with ICS or as a separate inhaler, azithromycin (given prophylactically).
***To express an interest for the ASYMPTOMATIC study please use the form provided and a member of the team will be in touch***