Management of Asthma in School-age Children on Therapy

NCT01526161 | Completed Phase 4 DMC

• 2 other identifiers: HTA 05/503/04ISRCTN03556343
• Study Type: interventional
• Target: 229
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Children; Therapy; Fluticasone; Salmeterol; Montelukast

Outcome Measures

Primary Outcomes (1)

• Number of asthma exacerbations requiring treatment with short courses of oral corticosteroids over 48 weeks from date of randomisation

  Between 2008 and 2010 for 48 weeks duration

Secondary Outcomes (9)

• Quality of Life as measured by the Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the Paediatric Asthma Caregivers Quality of Life Questionnaire (PACQLQ)

  Between 2008 and 2010 for 48 weeks duration

• Time from randomisation to first exacerbation requiring treatment with a short course of oral corticosteroids

  Between 2008 and 2010 for 48 weeks duration

• School attendance

  Between 2008 and 2010 for 48 weeks duration

• Hospital admissions

  Between 2008 and 2010 for 48 weeks duration

• Amount of rescue beta2 agonist therapy prescribed

  Between 2008 and 2010 for 48 weeks duration

Study Arms (3)

Inhaled Fluticasone propionate and salmeterol

EXPERIMENTAL

inhaled fluticasone propionate 100 micrograms and salmeterol 50 m

Drug: inhaled fluticasone propionate; Drug: salmeterol

Inhaled Fluticasone propionate and placebo

ACTIVE COMPARATOR

inhaled fluticasone propionate 100micrograms twice daily + placebo

Drug: inhaled fluticasone propionate

Inhaled Fluticasone propionate and Montelukast

ACTIVE COMPARATOR

inhaled fluticasone propionate 100micrograms twice daily + Montelukast

Drug: Montelukast

Interventions

inhaled fluticasone propionate DRUG

100 micrograms

Inhaled Fluticasone propionate and placebo; Inhaled Fluticasone propionate and salmeterol

salmeterol DRUG

50 m

Inhaled Fluticasone propionate and salmeterol

Montelukast DRUG

Double blind double dummy

Inhaled Fluticasone propionate and Montelukast

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Warren Lenney: lead

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Warren Lenney

  University Hospital of North Staffordshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Respiratory Child Health, UHNS and Keele University

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: February 3, 2012
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 3, 2012

Record last verified: 2012-01