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Management of Asthma in School-age Children On Therapy
ISRCTN ISRCTN03556343
DOI 10.1186/ISRCTN03556343
ClinicalTrials.gov identifier
EudraCT number
Public title Management of Asthma in School-age Children On Therapy
Scientific title
Acronym MASCOT
Serial number at source HTA 05/503/04
Study hypothesis Children whose asthma is uncontrolled on low dose Inhaled Corticosteroids (ICS) will have their control improved by prescribing 'add-on' therapies (long-acting beta-2 agonists and/or leukotriene receptor antagonists) in addition to low dose ICS treatment.

More details can be found at: http://www.hta.ac.uk/1599

Please note that, as of 11/05/2009, the anticipated start and end dates have been updated from 01/04/2008 and 31/03/2010 to 01/01/2009 and 30/09/2011, respectively.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the North West Research Ethics Committee on 3rd April 2008 (ref: 08/H1010/8).
Study design A prospective, controlled, double-blind, multicentre, randomised clinical trial
Countries of recruitment United Kingdom
Disease/condition/study domain Asthma (paediatric population)
Participants - inclusion criteria 1. Children with physician diagnosed asthma aged 6 years - 14 years 11 months
2. Those requiring frequent short-acting beta-2 agonist relief therapy greater than or equal to 7 puffs per week
3. Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough) resulting in:
3.1. Difficulty sleeping in the last week because of asthma symptoms and/or
3.2. Asthma has interfered with usual activities in the last week and/or
3.3. Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled General Practitioner (GP) or Accident and Emergency (A&E) Department visit or a hospital admission within the previous 6 months
4. Fully informed consent written (proxy) consent and assent, where appropriate
Participants - exclusion criteria 1. Children receiving long acting beta-2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS
2. Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders
Anticipated start date 01/01/2009
Anticipated end date 30/09/2011
Status of trial Completed
Patient information material
Target number of participants 900
Interventions 1. Inhaled fluticasone propionate 100 µg twice daily plus placebo tablet once daily
2. Inhaled fluticasone propionate 100 µg and salmeterol 50 µg twice daily (combination inhaler) plus placebo tablet once daily
3. Inhaled fluticasone propionate 100 µg twice daily plus montelukast 5 mg tablet once daily

There is a four week run-in period, followed by a 48 week intervention and follow up period (for those patients eligible at randomisation). Patients in the randomised phase will receive study treatment for the full 48 weeks.

Joint Sponsor:
Keele University (UK)
Research Services
Room DH 1.13, Dorothy Hodgkin Building
Keele, Staffordshire
ST5 5BG
United Kingdom
Tel: 01782 583 374
Fax: 01782 583 740
Email: j.m.garside@uso.keele.ac.uk
Website: http://www.keele.ac.uk/
Primary outcome measure(s) The main research objective is to determine, in 6 - 14 year old children with asthma, uncontrolled on low-dose ICS, whether their control can be improved by adding in a long-acting beta-2 agonist (salmeterol) or a leukotriene receptor antagonist (montelukast) as measured by a reduced number of exacerbations requiring treatment with oral corticosteroids over the 48 week study period.
Secondary outcome measure(s) 1. Quality of Life measured by the Juniper QoL questionnaire, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
2. Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
3. School attendance, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
4. Hospital admissions, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
5. Amount of rescue beta-2 agonist therapy prescribed, collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
6. Time from randomisation to treatment withdrawal (due to lack of efficacy or side effects), collected at baseline, randomisation, then +8 weeks, +24 weeks, +36 weeks and +48 weeks
7. Lung function (as assessed by spirometry), conducted at baseline/randomisation (T0) and randomisation + 48 weeks (T48)
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23380178
Contact name Prof  Warren  Lenney
  Address Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
  City/town Stoke-on-Trent
  Zip/Postcode ST4 7QB
  Country United Kingdom
Sponsor University Hospital of North Staffordshire NHS Trust (UK)
  Address Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
  City/town Staffordshire
  Zip/Postcode ST4 7QB
  Country United Kingdom
Date applied 08/11/2007
Last edited 24/07/2013
Date ISRCTN assigned 19/11/2007
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