None listed
Conditions
Brief summary
The global burden of childhood asthma is significant, and New Zealand has one of the highest prevalence rates in the world. Many children with asthma only use a short-acting beta-agonist (SABA) reliever inhaler, without a regular preventer (such as an inhaled corticosteroid, ICS). Whilst SABAs provide fast symptom relief, they do not treat the underlying inflammation that is commonly present, even in children with so-called “mild” asthma. Factors including the overestimation of asthma symptom control, reduced access to adequate medical treatment, and in some cases steroid aversion, all contribute to the increased asthma-related morbidity and mortality in this population. Inclusion of ICS with a beta-agonist reliever as default, in a 2 in 1 combination inhaler (i.e. budesonide-formoterol), has the potential to mitigate the risk of harm. Two recent studies in adults with mild asthma (SYMGA1 and Novel-START) found that budesonide-formoterol taken as needed reduced asthma attacks by more than 50% compared to salbutamol taken as needed. These findings led to a fundamental change in the way mild asthma in adults and adolescents is managed; the Global Initiative for Asthma (GINA) no longer recommends the use of beta-agonist monotherapy in this age group, instead promoting ICS-formoterol as the preferred option. Whether these findings translate to childhood asthma is unknown as there have been no randomised controlled trials of as-needed ICS-formoterol therapy in children. If comparable efficacy of this regimen is shown, then its implementation has the potential to markedly reduce asthma morbidity in children globally. We therefore propose an RCT to compare the safety and efficacy of two treatment regimens in mild asthma: 1. A combination inhaled corticosteroid (ICS) and Long Acting Beta Agonist (LABA) as required 2. SABA as required
Interventions
Inhaled Corticosteroid with Long-Acting Beta2-Agonist (ICS-LABA):
Budesonide-formoterol presurrised metered-dose inhaler 50micrograms/3micrograms, two puffs via spacer, as required for relief of asthma symptoms, for 52 weeks.
The intervention will be participant- and/or parent-administered.
There is no maximum daily frequency of administration of the intervention, however participants will receive a written asthma action plan detailing when to seek medical help (participant's using more than
Inhaled Corticosteroid with Long-Acting Beta2-Agonist (ICS-LABA): Budesonide-formoterol presurrised metered-dose inhaler 50micrograms/3micrograms, two puffs via spacer, as required for relief of asthma symptoms, for 52 weeks. The intervention will be participant- and/or parent-administered. There is no maximum daily frequency of administration of the intervention, however participants will receive a written asthma action plan detailing when to seek medical help (participant's using more than 12 puffs in one day will be advised to go to the hospital or see their doctor today). Adherence will not be monitored.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1) Aged five to 15 years 2) Doctor diagnosis of asthma (parent/participant or doctor-reported) AND a. SABA use on greater than or equal to 3 consecutive days in the last 12 months, AND/OR b. SABA use on greater than or equal to 2 days per month, on average, in the last 12 months, AND/OR c. Urgent medical review for worsening asthma in the last 12 months. 3. Registered with a General Practitioner
Exclusion criteria
1) Hospital admission (equal to or greater than 24 hours) for asthma in the last 12 months 2) Self-reported use of >6 SABA inhalers in the last 12 months (i.e. poor-control) 3) Any use of ICS, LABA, leukotriene receptor antagonist (LTRA), theophylline, anticholinergic agent or cromone in the last 6 months 4) Any use of systemic corticosteroids in the last 6 weeks 5) Any medical condition which, at the Investigator’s discretion, may present a safety risk or impact the feasibility of the study or the study results (including, but not limited to, other significant respiratory comorbidities, such as cystic fibrosis and bronchiectasis) 6) Any known or suspected contraindications to the medications prescribed in the study or their respective excipients 7) Previous life-threatening asthma (Intensive Care Unit admission) 8) Unable or unwilling to switch from current asthma treatment regimen 9) Unable or unwilling to provide written informed consent (parent(s)/guardian(s)) or assent/consent (participant) 10) Self-reported current pregnancy or breast feeding at the time of enrolment
Outcome results
None listed