Condition category
Respiratory
Date applied
08/11/2007
Date assigned
19/11/2007
Last edited
06/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Warren Lenney

ORCID ID

Contact details

Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
ST4 7QB
United Kingdom

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 measures

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

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

www.keele.ac.uk

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23380178

Publication citations

  1. 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.

Additional files

Editorial Notes

06/06/2016: Plain English summary added. 11/05/2009: the overall trial start and end dates were changed from 01/04/2008 and 31/03/2010 to 01/01/2009 and 30/09/2011, respectively.