Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    8283197 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02758873
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sussex

Brief 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.


Condition or disease Intervention/treatment Phase
Asthma Genetic: Personalised medicine (Salmeterol) Genetic: Personalised medicine (Montelukast) Other: Standard care Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent/Guardian/Participant is willing and able to provide informed consent/assent
  • Physician-diagnosed asthma
  • Aged 12-18 years
  • Taking inhaled corticosteroids (ICS) with/without second line controller (i.e. LABA/LTRA)

Exclusion Criteria:

  • Parent/Guardian/Participant is unwilling or unable to give informed consent/assent
  • Known contraindication to montelukast or salmeterol
  • Other major airway or lung disease, e.g. chronic lung disease of prematurity, cystic fibrosis, and abnormal airway anatomy
  • Pregnant or lactating females (if participants become pregnant during the course of the study they will be asked to inform the research team and be withdrawn from the study)
  • Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
  • On step 4 asthma control medication e.g. taking Theophylline, Slo-phylin, Uniphyllin
  • Unable to provide saliva/buccal cells for genotyping

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
Brighton & Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 5BE
Kent, Surrey & Sussex CCGs
Gillingham, Kent, United Kingdom, ME8 0NZ
NHS Grampian
Aberdeen, United Kingdom, AB25 2ZG
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Bart's Health NHS Trust
London, United Kingdom, NW1 0PE
Sponsors and Collaborators
University of Sussex
Investigators
Layout table for investigator information
Principal Investigator: Somnath Mukhopadhyay, FRCPCH Brighton and Sussex University Hospitals NHS Trust

Publications:

Layout table for additonal information
Responsible Party: University of Sussex
ClinicalTrials.gov Identifier: NCT02758873     History of Changes
Other Study ID Numbers: 14/054/MUK
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol Xinafoate
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers