EUCTR2008-000511-16-GB
Active, not recruiting
Phase 1
Management of Asthma in School age Children On Therapy - MASCOT
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic asthma (paediatric population)
- Sponsor
- Keele University
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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