A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist maintenance and/or reliever therapy versus standard maintenance with separate reliever therapy in children with mild, moderate and severe asthma.

Phase 3

Recruiting

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12622001217796
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients of any gender age five to 11 years (inclusive)
2. Doctor diagnosis of asthma (self-report by parent/participant or healthcare provider-reported)
3. Use of ICS or ICS-LABA maintenance plus SABA reliever therapy (corresponding to
GINA step 2, 3 or 4) in the 6 months prior to Visit 1
4. Registered with a General Practitioner
5. Satisfactory Turbuhaler technique
6. Inspiratory flow measurement of between 30 and 90 L/min
7. Provision of written informed consent (parent/guardian) and assent (participant)
8. Able and willing to switch from current treatment regimen

For randomisation at Visit 2, participants should fulfil the following criterion:

9. Satisfactory Turbuhaler technique
10. Inspiratory flow measurement of between 30 and 90 L/min

Exclusion Criteria

1. Already using ICS-formoterol or ICS-Salbutamol as a reliever
2. Any use of high dose ICS-LABA (New Zealand Child Asthma Guidelines Step 5), biologics, maintenance oral corticosteroids (i.e. GINA Step 5), or leukotriene receptor antagonists in the last 6 months
3. Any use of systemic corticosteroids in the 6 weeks prior to Visit 1
4. Use of a beta-blocker in the 6 months prior to Visit 1
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 hypersensitivity (including rash, urticaria, angioedema, bronchospasm and anaphylactic reaction) to the active substances prescribed in the study (budesonide, formoterol, terbutaline), lactose or milk protein (excipient)
7. Any intravenous therapy for the treatment of asthma, in the last year.
8. Previous Intensive Care Unit admission for asthma, or ventilation for asthma, ever
9. Participation in another clinical trial of an investigational medicinal product in the 30 days prior to Visit 1

For randomisation at Visit 2, participants are excluded from the study if the following criteria apply:

10. Any severe exacerbation, or 2 moderate exacerbations (per protocol defined criteria) and/or a change in asthma treatment other than run-in study medication from Visit 1 until Visit 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified