Prescribing Asthma Controller Medication According to Gene Status to Improve Quality of Life in Young People With Asthma (PACT)
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|ClinicalTrials.gov Identifier: NCT02758873|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : May 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Genetic: Personalised medicine (Salmeterol) Genetic: Personalised medicine (Montelukast) Other: Standard care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prescribing Asthma Controller Medication According to Gene Status to Improve Quality of Life in Young People With Asthma|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Personalised Medicine
If an add-on controller is required, young people in this arm will be prescribed personalised medicine by results of the genotyping for the adrenergic beta2-receptor gene (ADRB2). Health professional's will be advised to prescribe inhaled salmeterol as 'add-on' controller if trial participants have the Gly/Gly variant on ADRB2, and montelukast if they have Arg/Arg or Arg/Gly variant on ADRB2.
Genetic: Personalised medicine (Salmeterol)
If participants require add-on medication and have the Gly/Gly variant on the ADRB2, salmeterol will be prescribed.
Other Name: Salmeterol
Genetic: Personalised medicine (Montelukast)
If participants require add-on medication and have the Arg/Arg or Arg/Gly variant on the ADRB2, montelukast will be prescribed.
Other Name: Montelukast
Active Comparator: Standard care
If an add-on controller is required, young people will be prescribed medication as per the choice of the primary or secondary care physician, without knowledge of genotypic status.
Other: Standard care
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.
Other Name: Salmeterol or montelukast
- Asthma Quality of Life Questionnaires with Standardised Activities (AQLQ(S)) [ Time Frame: Past two weeks ]A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Participants are asked to think about how they have been during the previous 2 weeks and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered).
- Asthma Control Questionnaire (ACQ) [ Time Frame: Past week ]The ACQ has 6 questions (the top scoring 5 symptoms, and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment).
- Health care utilisation [ Time Frame: 3 months ]Participants will be asked to record how many times they have had to visit their GP or asthma nurse (outside of routine asthma review), A&E or hospital as a result of their asthma over the previous 3 months. Total scores for health care utilisation will be summed over the 12-month study period to create a total score for health care utilisation for each participant. Participants will be asked to enter this data via on the online questionnaire at each 3-month follow up.
- Medication use [ Time Frame: 3 months ]Participants will be asked to record any courses of oral corticosteroids for asthma and any other medication use over the last 3 months. Medication use (scored by each type of medicinal product) will be summed across the 12 month study period to create total number of additional medicinal product use for each participant. Participants will be asked to enter this data via on the online questionnaire at each 3-month follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758873
|Brighton & Sussex University Hospitals NHS Trust|
|Brighton, East Sussex, United Kingdom, BN2 5BE|
|Kent, Surrey & Sussex CCGs|
|Gillingham, Kent, United Kingdom, ME8 0NZ|
|Aberdeen, United Kingdom, AB25 2ZG|
|Dundee, United Kingdom, DD1 9SY|
|Bart's Health NHS Trust|
|London, United Kingdom, NW1 0PE|
|Principal Investigator:||Somnath Mukhopadhyay, FRCPCH||Brighton and Sussex University Hospitals NHS Trust|