Plain English Summary
Background and study aims
Asthma is a common long-term condition that can cause coughing, wheezing, chest tightness and breathlessness. It 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 recommend when this treatment is not working other treatments should be started. Studies to support this have taken place in adults but not with children.
Who can participate?
Children with asthma aged 6 - 14
What does the study involve?
If patients are instructed how to use inhalers and are given information about asthma, they can control their disease much better. The first part of this study, lasting 4 weeks, makes sure that the children and their families understand how to use their inhaler. All participating children are given the same steroid inhaler to use and after 4 weeks those still with symptoms enter the study proper which lasts for 48 weeks. During this part of the study the children are randomly allocated to be given one of three treatments: a steroid inhaler and a dummy tablet; an inhaler containing a steroid and a long-acting reliever and a dummy tablet; or a steroid inhaler and an active tablet. What matters to children is how they feel, are they able to run around and play with friends, and are they well enough to go to school. We assess which of the above treatments best allow these to happen by asking the parents and children to fill in questionnaires on four occasions during the study. We also assess which treatment best prevents the need for short courses of steroid tablets during the study. These are commonly given when asthma symptoms worsen.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
North Staffordshire Medical Institute (UK)
When is the study starting and how long is it expected to run for?
January 2009 to September 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Prof. Warren Lenney
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 05/503/04
Study information
Scientific title
Management of Asthma in School-age Children On Therapy
Acronym
MASCOT
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.nets.nihr.ac.uk/projects/hta/0550304
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0013/51223/PRO-05-503-04.pdf
Ethics approval
North West Research Ethics Committee, 03/04/2008, ref: 08/H1010/8
Study design
Prospective controlled double-blind multicentre randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Asthma (paediatric population)
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Fluticasone propionate, salmeterol, montelukast
Primary outcome measure
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 measures
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)
Overall trial start date
01/01/2009
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
900
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Staffordshire Medical Institute
Stoke-on-Trent
ST4 7QB
United Kingdom
Sponsor information
Organisation
University Hospital of North Staffordshire NHS Trust (UK)
Sponsor details
Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
Staffordshire
ST4 7QB
United Kingdom
Sponsor type
Government
Website
Organisation
Keele University (UK)
Sponsor details
Research Services
Room DH 1.13
Dorothy Hodgkin Building
Keele
ST5 5BG
United Kingdom
+44 (0)1782 583 374
j.m.garside@uso.keele.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23380178
Publication citations
-
Results
Lenney W, McKay AJ, Tudur Smith C, Williamson PR, James M, Price D, , Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety., Health Technol Assess, 2013, 17, 4, 1-218, doi: 10.3310/hta17040.