Management of Asthma in School-age Children on Therapy (MASCOT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Warren Lenney, University Hospital of North Staffordshire
ClinicalTrials.gov Identifier:
NCT01526161
First received: August 10, 2011
Last updated: February 2, 2012
Last verified: January 2012
  Purpose

Asthma 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 are started. Studies to support this have taken place in adults but not with children. 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, will make sure the children and their families understand how to use their inhaler. All children will be given the same steroid inhaler to use and after 4 weeks those still with symptoms will enter the study proper which lasts for 48 weeks. During this part of the study the children will be given one of three treatments. These are:- a steroid inhaler + a dummy tablet, an inhaler containing a steroid and a long-acting reliever + a dummy tablet or a steroid inhaler + an active tablet. In this way the patient, the family and the researchers will not know which of the three treatments the child is taking until the code is broken at the end of the study.

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. The investigators will assess which of the above treatments best allow these to happen by asking the parents and children to fill in questionnaires on 4 occasions during the study. The investigators will also see which treatment best prevents the need for short courses of steroids tablets during the study. These are commonly given when asthma symptoms worsen.

Most children will be started in the study through their general practitioner clinic. It will take one year to enroll all 900 children. Once enrolled the children will be followed-up in hospital centres. Much of the funding will be required to recruit and follow-up the children, train everyone to the same standard and develop and administer the questionnaires and health economic assessments. Asthma care is an expensive. The investigators will look at the costs and assess which treatment offers most benefit. The team has experience and ability in this field and will ensure the results are well publicised. Any child can withdraw from the study at any time.


Condition Intervention Phase
Asthma
Drug: inhaled fluticasone propionate
Drug: salmeterol
Drug: Montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Management of Asthma in School-age Children on Therapy

Resource links provided by NLM:


Further study details as provided by University Hospital of North Staffordshire:

Primary Outcome Measures:
  • Number of asthma exacerbations requiring treatment with short courses of oral corticosteroids over 48 weeks from date of randomisation [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life as measured by the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the Paediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ) [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • School attendance [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Hospital admissions [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Amount of rescue beta2 agonist therapy prescribed [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Time from randomisation to treatment withdrawal (due to lack of efficacy or side effects) [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Lung function at 48 weeks (as assessed by spirometry) [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Cost effectiveness [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Between 2008 and 2010 for 48 weeks duration ] [ Designated as safety issue: Yes ]

Enrollment: 229
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Fluticasone propionate and salmeterol
inhaled fluticasone propionate 100 micrograms and salmeterol 50 m
Drug: inhaled fluticasone propionate
100 micrograms
Drug: salmeterol
50 m
Active Comparator: Inhaled Fluticasone propionate and placebo
inhaled fluticasone propionate 100micrograms twice daily + placebo
Drug: inhaled fluticasone propionate
100 micrograms
Active Comparator: Inhaled Fluticasone propionate and Montelukast
inhaled fluticasone propionate 100micrograms twice daily + Montelukast
Drug: Montelukast
Double blind double dummy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with physician diagnosed asthma aged 6 years -14 years, 11months
  • Those requiring frequent short-acting beta2 agonist relief therapy ≥ 7 puffs in the past seven days
  • Those with symptoms of asthma (i.e. wheeze, shortness of breath but not cough alone) resulting in:

    i. Nocturnal wakening in the last week because of asthma symptoms and/or ii. Asthma has interfered with usual activities in the last week and/or iii. Those who have had exacerbations, defined as a short course of oral corticosteroids, an unscheduled GP or A&E Department visit or a hospital admission within the previous 6 months

  • Fully informed written (proxy) consent and assent, where appropriate

Exclusion Criteria:

  • Children receiving long acting beta2-agonists, leukotriene receptor antagonists, regular theophylline therapy or high dose ICS >1000micrograms and unlicensed beclometasone dipropionate or equivalent (at the discretion of the investigator)
  • Children with other respiratory diseases, cystic fibrosis, cardiac disease or immunological disorders
  • Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526161

Sponsors and Collaborators
Professor Warren Lenney
Investigators
Principal Investigator: Warren Lenney University Hospital of North Staffordshire
  More Information

No publications provided

Responsible Party: Professor Warren Lenney, Professor of Respiratory Child Health, UHNS and Keele University, University Hospital of North Staffordshire
ClinicalTrials.gov Identifier: NCT01526161     History of Changes
Other Study ID Numbers: HTA 05/503/04, ISRCTN03556343
Study First Received: August 10, 2011
Last Updated: February 2, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital of North Staffordshire:
Asthma
Children
Therapy
Fluticasone
Salmeterol
Montelukast

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Montelukast
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists

ClinicalTrials.gov processed this record on July 22, 2014