A randomIsed controlled trial of budesonide-formoterol vs terbutaline for symptom relief in adults with mild-moderate asthma on inhaled corticosteroid maintenance therapy

Phase 4

Active, not recruiting

• Conditions: Asthma; Respiratory - Asthma

• Registration Number: ACTRN12622001304729
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

Aged 16 to 75 years
- Self-reported doctor’s diagnosis of asthma for >/= 6 months prior to visit 1
- Current use (within the last 3 months) of either:
Inhaled corticosteroid (ICS) maintenance (any dose) plus a short-acting beta-agonist (SABA) reliever inhaler OR
SABA reliever inhaler only OR
ICS/LABA combination reliever inhaler only
- Average use of SABA reliever on >/= 2 episodes per week, over the last 12 weeks
- FeNO >/= 25 ppb at screening
- Ability to perform FeNO measurements at home on a regular basis
- Ability to use the turbuhaler device
- Self-reported registered with a General Practitioner

Exclusion Criteria

- Current use (within the last 3 months) of other asthma medications including: ICS/long-acting beta-agonist (LABA) combination inhalers, leukotriene receptor antagonists, theophylline, regular oral corticosteroids, sodium cromoglycate or anticholinergic agents
- Average use of ICS/LABA combination reliever inhaler on = 8 episodes per week, over the last 12 weeks
- Any use of systemic corticosteroids in the last 6 weeks
- Self-reported diagnosis of COPD, bronchiectasis, vocal cord dysfunction or interstitial lung disease
- Self-reported current smokers, defined as someone who has smoked more than 100 cigarettes (including hand rolled cigarettes, cigars, cigarillos, etc), or has used an e-cigarette on more than 100 occasions in their lifetime, and has smoked or vaped in the last 28 days
- Self-reported greater than 20 pack year smoking history, or asthma diagnosis after the age of 40 years in current or ex-smokers with >/=10 pack year history
- Self-reported congestive heart failure, atrial fibrillation, unstable coronary artery disease, or other clinically significant cardiac disease
- 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
- Any known or suspected contraindications to the medications prescribed in the study or their respective excipients
- Previous life-threatening asthma (Intensive Care Unit admission for asthma ever)
- Unable or unwilling to switch from current asthma treatment regimen
- Unable or unwilling to provide written informed consent
- Self-reported current or planned pregnancy or breast feeding at the time of enrolment
- Self-report of participation in another research trial involving an unapproved investigational medicinal product, in the past 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fraction of exhaled Nitric Oxide (FeNO) measured using the Vivatmo me (Bosch) FeNO analyser[ Week 26 from the date intervention commenced]