A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist reliever therapy regimen in children with mild asthma

Phase 3

Active, not recruiting

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12620001091998
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 360

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
; 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
; 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified