Management of Asthma in School age Children On Therapy - MASCOT
- Conditions
- Chronic asthma (paediatric population)MedDRA version: 9.1 Level: LLT Classification code 10049106 Term: Asthma chronicMedDRA version: 9.1 Level: LLT Classification code 10049868 Term: Asthma exacerbation prophylaxis
- Registration Number
- EUCTR2008-000511-16-GB
- Lead Sponsor
- Keele University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
1.Children with physician diagnosed asthma aged 6 years -14 years, 11months
2.Those requiring frequent short-acting beta2 agonist relief therapy = 7 puffs per week
3.Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough alone) resulting in:
i.Nocturnal wakening in the last week because of asthma symptoms and/or
ii.Asthma has interfered with usual activities in the last week and/or
iii.Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled GP or A&E Department visit or a hospital admission within the previous 6 months.
4.Fully informed written (proxy) consent and assent, where appropriate
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Children receiving long acting beta2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS (>1000micrograms and unlicensed beclometasone dipropionate or equivalent at the discretion of the investigator).
2.Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders.
3.Non-English speaking
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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