None listed
Conditions
Brief summary
Asthma is the most common chronic disease of childhood. In New Zealand (NZ), prevalence rates for paediatric asthma, and for severe asthma, are amongst the highest in the world. Asthma is a chronic inflammatory disease of the small airways. Swelling of the airway lining, and constriction of the surrounding muscle causes them to narrow. Many children only use a short-acting beta-agonist (SABA) reliever inhaler, such as Salbutamol. These inhalers provide fast symptom relief, but do not treat the underlying inflammation. Inhaled corticosteroids (ICS) are required for this and are the mainstay of asthma maintenance therapy. Despite best efforts, ICS are under-described by clinicians and underutilised by patients. This leaves the airway swelling unchecked, which increases the risk of poor control and asthma attacks. 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 (RCTs) in children. If comparable efficacy of this regimen is shown, then its implantation has the potential to markedly reduce asthma morbidity in children globally. This study aims to determine the efficacy and safety of as-needed budesonide-formoterol (ICS-LABA) reliever therapy compared with salbutamol (SABA) reliever therapy (current standard treatment) in children 24 to 59 months with mild asthma/recurrent wheeze. We plan an open-label randomised controlled trial to compare these two treatment options in 280 children. Eligible participants will be recruited at sites in NZ and randomised (1:1) to receive either budesonide-formoterol as needed or salbutamol as needed.
Interventions
Inhaled Corticosteroid with Long-Acting-Beta2-Agonist (ICS-LABA):
Budesonide-formoterol pressurised metered-dose inhaler 100micrograms/6micrograms, one puff via spacer, as required for relief of asthma/wheeze symptoms, for 52 weeks.
The intervention will be parent/guardian administered.
There is no maximum daily frequency of administration of the intervention, however participants will receive a personalised written action plan detailing when to seek medical help (participant's using more tha
Inhaled Corticosteroid with Long-Acting-Beta2-Agonist (ICS-LABA): Budesonide-formoterol pressurised metered-dose inhaler 100micrograms/6micrograms, one puff via spacer, as required for relief of asthma/wheeze symptoms, for 52 weeks. The intervention will be parent/guardian administered. There is no maximum daily frequency of administration of the intervention, however participants will receive a personalised written action plan detailing when to seek medical help (participant's using more than 6 puffs in one day will be advised to go to the hospital or see their doctor today). Adherence will not be monitored. Children and their parent/guardian will attend a face-to-face appointment at a clinic space (Visit 1 - approximately 60-90 minutes) with a member of the research team. This is to ascertain their eligibility for the study, and then to randomise to a treatment arm. Children aged 4 years will be assessed as to the suitability of using a spacer with no mask versus with a mask when administering the medication. Any child under 3 years of age or who can't demonstrate adequate spacer use will be educated to use a mask attached to the spacer for all treatments. Education will be given on correct inhaler use (children will be instructed to take six breaths from the spacer for each puff of medication) and a written action plan will be completed and discussed with the child and their parent/guardian. Inhaler use, spacer technique and asthma action plan will be reassessed at Visits 2, 3 and 4 and re-education provided as necessary.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
24 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. Aged 24 to 59 months; AND 2. >=3 wheezing episodes in the last 12 months (at least one doctor or nurse prescriber diagnosed); AND 3. Prescription of SABA in the last 12 months.
Exclusion criteria
1. Previous life-threatening asthma/wheeze (intensive care unit admission or intravenous treatment); OR 2. Self-reported use of more than six SABA MDIs in the last 12 months (i.e. poorly controlled); OR 3. Use of asthma medications other than SABA (ICS, LABA, leukotriene receptor antagonist, theophylline, anticholinergic agent or cromone) in last 3 months; OR 4. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrhythmia; OR 5. Unable or unwilling to switch from current treatment regimen; OR 6. Ex-preterm infant (born <37 weeks' gestation); OR 7. Children living outside urban areas (i.e. significant distance from ambulance or hospital).
Outcome results
None listed