Status:
TERMINATED
PRISTINE - Personalised Approach to Improve aSThma prescrIbing iN childrEn
Lead Sponsor:
Brighton and Sussex University Hospitals NHS Trust
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE4
Brief Summary
Asthma is one of the most common chronic diseases affecting children in the UK. Poorly controlled asthma manifests with chronic cough, wheeze and shortness of breath which in-turn has a significant ne...
Detailed Description
Asthma is a common chronic illness in children and young people. It affects, for example, an average of two children in every UK classroom. Initial treatment usually consists of salbutamol used on dem...
Eligibility Criteria
Inclusion
- Parent/Guardian/Participant is willing and able to give informed consent/assent
- Physician-diagnosed asthma that is inadequately controlled as per view of doctor (for example, history of at least two emergency visits to GP or hospital over the previous year, frequent use of blue inhaler (three times or more per week))
- Aged 5-11 years (inclusive)
- Children who are already on at least 400 micrograms per day inhaled beclomethasone or equivalent and hence ready to be prescribed inhaled long-acting beta2 agonists and/or other add-on medication or are already on inhaled long-acting beta2 agonists and/or other add-on medication
Exclusion
- Parent/Guardian/Participant is unwilling or unable to give informed consent/assent
- Known contraindication to montelukast or salmeterol
- Other known significant airway or lung disease (e.g. chronic lung disease of prematurity, cystic fibrosis or congenital airway abnormalities) or other co-existing serious disease such as congenital cardiac disease
- Poor inhaler technique and/or history of poor adherence on checking following standard procedure at the clinic
- Participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03269318
Start Date
July 1 2017
End Date
August 30 2019
Last Update
December 18 2019
Active Locations (1)
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1
BrightonNHS
Brighton, East Sussex, United Kingdom, BN2 5BE