Status:
COMPLETED
Management of Asthma in School-age Children on Therapy
Lead Sponsor:
Professor Warren Lenney
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
Brief Summary
Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative medicine in the form of low-dose steroids using an inhaler. The National Asthma Treatment Guidelines recomme...
Detailed Description
Asthma remains the most common medical condition seen in children in primary care and the most frequent cause for medical paediatric hospital admission. It affects 1 in 8 children nationwide, approxim...
Eligibility Criteria
Inclusion
- Children with physician diagnosed asthma aged 6 years -14 years, 11months
- Those requiring frequent short-acting beta2 agonist relief therapy ≥ 7 puffs in the past seven days
- 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
- Fully informed written (proxy) consent and assent, where appropriate
Exclusion
- 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)
- Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders
- Non-English speaking
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT01526161
Start Date
April 1 2009
End Date
January 1 2011
Last Update
February 3 2012
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