A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist as maintenance and reliever therapy versus as prescribed maintenance with salbutamol as reliever therapy in children with moderate and severe asthma.

A 52 week, open-label, randomised, multi-centre, parallel group, phase III, controlled trial in children aged 4 to 11 years with moderate and severe asthma, evaluating the efficacy and safety of Budesonide-formoterol (Vannair®) as single maintenance and reliever therapy versus as prescribed maintenance asthma therapy and salbutamol (Ventolin®) as reliever therapy.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001339640

Acronym

SMARTCARE: Single Maintenance And Reliever Therapy - Children’s Anti-inflammatory REliever study

Enrollment

166

Registered

2023-12-19

Start date

2024-01-10

Completion date

2027-12-31

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised controlled trial aims to determine the best treatment for children between the ages of 4 and 11 years of age who have moderate to severe asthma. We will compare two asthma treatment regimens in 376 children with moderate and severe asthma to find out which is better at reducing asthma exacerbations. Eligible participants will be recruited at sites in New Zealand and randomised to either a combination inhaled corticosteroid - long acting beta2 agonist (Vannair) asthma inhaler used as single maintenance and reliever therapy (SMART therapy) OR as prescribed asthma maintenance therapy and short-acting beta2 agonist (Ventolin) asthma inhaler as reliever therapy.

Interventions

Combination Inhaled Corticosteroid + Long-Acting Beta2-Agonist (ICS-LABA). Budesonide-formoterol (100micrograms/6micrograms) metered dose inhaler (MDI) (Vannair®) as single maintenance and reliever therapy (SMART) via spacer (Airflow Space Chamber Plus 220 ml). Regimen and dose will be adjusted according to the Global INitiative for Asthma (GINA) step at study entry, with maintenance and/or reliever use as needed for relief of asthma symptoms, for 52 weeks. GINA step 2: 1 inhalation once daily + 1 inhalation as needed GINA step 3: 1 inhalation once OR twice daily + 1 inhalation as needed GINA step 4: 2 inhalations twice daily + 1 inhalation as needed GINA steps will be assessed by the investigator at study entry and aligned to existing treatment (per the steroid equivalence table in the protocol). During the course of the study, participant’s GINA step will be re-assessed and adjusted by the investigator based on the escalation criteria. Participants will be asked to contact investigators for urgent review (unscheduled visit) within seven days of a severe asthma exacerbation. During this review, participants will potentially have their standard treatment stepped up in accordance with the SMARTCARE stepwise treatment algorithm approach, if not already done so by their usual doctor or the medical team treating their acute asthma. 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 6 reliever inhalations in one day will be advised to go to the hospital or see their doctor today). Adherence will not be monitored.

Combination Inhaled Corticosteroid + Long-Acting Beta2-Agonist (ICS-LABA). Budesonide-formoterol (100micrograms/6micrograms) metered dose inhaler (MDI) (Vannair®) as single maintenance and reliever therapy (SMART) via spacer (Airflow Space Chamber Plus 220 ml/ eChamber Turbo 220 ml). Regimen and dose will be adjusted according to the Global INitiative for Asthma (GINA) step at study entry, with maintenance and/or reliever use as needed for relief of asthma symptoms, for 52 weeks. GINA step 2: 1 inhalation once daily + 1 inhalation as needed GINA step 3: 1 inhalation once OR twice daily + 1 inhalation as needed GINA step 4: 2 inhalations twice daily + 1 inhalation as needed GINA steps will be assessed by the investigator at study entry and aligned to existing treatment (per the steroid equivalence table in the protocol). During the course of the study, participant’s GINA step will be re-assessed and adjusted by the investigator based on the escalation criteria. Participants will be asked to contact investigators for urgent review (unscheduled visit) within seven days of a severe asthma exacerbation. During this review, participants will potentially have their standard treatment stepped up in accordance with the SMARTCARE stepwise treatment algorithm approach, if not already done so by their usual doctor or the medical team treating their acute asthma. 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 6 reliever inhalations in one day will be advised to go to the hospital or see their doctor today). Adherence will not be monitored.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

4 Years to 11 Years

Healthy volunteers

Inclusion criteria

1. Aged 4 to 11 years 2. Doctor or Nurse Practitioner (NP) diagnosis of asthma (self-report by parent/participant or healthcare provider-reported) 3. Use of maintenance ICS or ICS-LABA + SABA reliever therapy in the last 6 months (i.e. GINA step 2, 3 and 4) 4. Registered with a General Practitioner (GP) 5. Willing and able to switch from current treatment regimen

Exclusion criteria

1. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrythmia 2. Previous life-threatening asthma (ICU admission ever or intravenous (IV) treatment in last 2 years) 3. Already using ICS-LABA as a reliever 4. GINA step 5 (few children only, brittle asthma, and potentially difficult to manage in an RCT without regular face-to-face contact); use of biologics, high dose ICS-LABA, maintenance oral corticosteroids, or leukotriene receptor antagonists in the last 6 months 5. Systemic corticosteroids in last 6 weeks prior to Visit 1 6. Any known or suspected hypersensitivity (including rash, urticaria, angioedema, bronchospasm and anaphylactic reaction) to the active substances in the study (budesonide, formoterol, salbutamol) 7. Participation in another clinical trial of an investigational medicinal product in the 30 days prior to Visit 1 8. Ex-preterm infant (born <37 weeks)

Outcome results