ASYMPTOMATIC

• Research type

  Research Study

• Full title

  Assessing SYmptom-driven versus Maintenance Preventer Therapy for the Outpatient Management of AsThma In Children (ASYMPTOMATIC): A non-inferiority, pragmatic, randomised controlled trial using routinely collected outcome data.

• IRAS ID

  297649

• Contact name

  Ian Sinha

• Contact email

  iansinha@liv.ac.uk

• Sponsor organisation

  Alder Hey Children's NHS Foundation Trust

• Eudract number

  2021-003687-26

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  Asthma is the commonest long-term disease in children in the UK. It causes cough and difficulty
  breathing. The main treatment for asthma is a preventer inhaler, containing steroids, which prevents irritation of the airways. For many years we have advised children with asthma to use their preventer inhaler every day. However, new guidelines recommend that taking a preventer inhaler every day might not be required in all children. These guidelines are based on results of studies in adults, and some teenagers, with asthma. But, asthma in adults is different from asthma in children and so we need to do the ASYMPTOMATIC trial to provide evidence on whether taking a preventer inhaler only when a child, with mild asthma, has symptoms is as effective as taking it every day.

  The study will involve around 250 GP practices across the UK. Children and young people, with mild asthma, who choose to take part will be randomly assigned to one of two different approaches to using the preventer inhaler, for 12 months.
  1. Taking their inhaler it every day
  2. Taking their inhaler only when they have symptoms of asthma.

  We want to find out whether there is a difference between the two approaches in terms the chances of having an asthma attack, asthma symptoms, hospital admissions, and overall quality of life.

  We need around 1800 children and young people to take part. To make this easier for families we will use a database, called the Clinical Practice Research Datalink, to collect information about whether participants have had an asthma attack, or have needed to go to hospital. This means that there are no extra appointments for participants. To find out about quality of life and asthma symptoms we will ask participants to complete short questionnaires online at baseline, 4, 8 and 12 months.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  21/LO/0555

• Date of REC Opinion

  23 Sep 2021

• REC opinion

  Further Information Favourable Opinion