Management of asthma in school-age children on therapy

ISRCTN	ISRCTN03556343
DOI	https://doi.org/10.1186/ISRCTN03556343
ClinicalTrials.gov (NCT)	NCT01526161
Protocol serial number	HTA 05/503/04
Sponsors	University Hospital of North Staffordshire NHS Trust (UK), Keele University (UK), University Hospital of North Staffordshire NHS Trust
Funder	Health Technology Assessment Programme

Submission date: 08/11/2007
Registration date: 19/11/2007
Last edited: 13/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Warren Lenney
Scientific

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

Study information

Primary study design	Interventional
Study design	Prospective controlled double-blind multicentre randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Management of Asthma in School-age Children On Therapy
Study acronym	MASCOT
Study objectives	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(s)	North West Research Ethics Committee, 03/04/2008, ref: 08/H1010/8
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Fluticasone propionate, salmeterol, montelukast
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.
Key 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)
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	900
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

North Staffordshire Medical Institute

Stoke-on-Trent
ST4 7QB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/02/2020: ClinicalTrials.gov number added.
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.