Management of asthma in school-age children on therapy
| ISRCTN | ISRCTN03556343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03556343 |
| ClinicalTrials.gov number | NCT01526161 |
| Secondary identifying numbers | HTA 05/503/04 |
- 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
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
Scientific
Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
ST4 7QB
United Kingdom
Study information
| Study design | Prospective controlled double-blind multicentre randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2009 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
ST4 7QB
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
Staffordshire
ST4 7QB
England
United Kingdom
University/education
Research Services
Room DH 1.13, Dorothy Hodgkin Building
Keele
ST5 5BG
England
United Kingdom
| Phone | +44 (0)1782 583 374 |
|---|---|
| j.m.garside@uso.keele.ac.uk | |
| Website | www.keele.ac.uk |
Not defined
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No |
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.
