CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 241 enrolled
Drug / intervention
Personalised medicine (Salmeterol) +2 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02758873
NCT02758873N/ACompleted

Prescribing Asthma Controller Medication According to Gene Status to Improve Quality of Life in Young People With Asthma

University of Sussex·interventional·Posted May 3, 2016·Updated Apr 16, 2020

In Brief

A clinical study evaluating Personalised medicine (Salmeterol), Personalised medicine (Montelukast), and 1 other intervention for Asthma. Completed, enrolled 241 participants across 5 sites.

Detailed Summary

One in every 11 children in the United Kingdom (UK) has asthma. Children with asthma cough, wheeze and have difficulty breathing. The symptoms which children experience can mean they miss school and makes it difficult for children to take part in playground games and sports. Some have to be admitted to hospital. In fact, in the UK a child is admitted to hospital every 18 minutes because of their asthma. Effective medicines are available, but a child's response to these medicines is currently unpredictable. This project focuses on an asthma controller medicine called salmeterol. According to reports, tens of thousands of children may be taking this medicine in the UK, but evidence suggests it might not work for around one in seven of them. The study team are investigating whether a new approach to treatment, where prescribing is personalised according to a child's genetic make-up, improves the child's quality of life and provides better control of their asthma. Treatment that is tailored in this way to a person's genetic features is often called 'personalised medicine'. At the moment, doctors commonly prescribe salmeterol to relieve asthma symptoms if children do not benefit enough from other medicines. But evidence suggests salmeterol may not work properly in children with a certain genetic makeup. The study team are investigating whether it helps to take children and young people's genetic makeup into account when deciding whether to give them salmeterol or an alternative medicine called montelukast. A simple and inexpensive saliva test can provide the information needed to guide decision making.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Personalised medicine (Salmeterol)genetic

If participants require add-on medication and have the Gly/Gly variant on the ADRB2, salmeterol will be prescribed.

Personalised medicine (Montelukast)genetic

If participants require add-on medication and have the Arg/Arg or Arg/Gly variant on the ADRB2, montelukast will be prescribed.

Standard careother

If participants require add-on medication in the arm, they will be prescribed either salmeterol or montelukast according to health professional's choice based on current guidelines.