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Protocol for the INFORM ASTHMA Trial: budesonide-formoterol reliever in adults with asthma on maintenance inhaled
Jonathan Noble1,2, Orlagh Bean1, Pepa Bruce1
1Medical Research Institute of New Zealand, Wellington, New Zealand.
Background:
International asthma guidelines recommend inhaled corticosteroid (ICS)/formoterol in preference to short-acting β2-agonist (SABA) reliever-based regimens as reliever therapy in adults and adolescents of all asthma severities. A major limitation to this recommendation is the absence of randomised controlled trial (RCT) efficacy and safety data for this approach in patients who continue to use maintenance ICS. The anti-inflammatory effect of ICS/formoterol reliever therapy on airway inflammation is also not well characterised.
Objective:
The objective of the present study is to determine the anti-inflammatory effect, efficacy and safety of budesonide-formoterol reliever therapy versus terbutaline reliever therapy in adults with asthma on maintenance ICS therapy. Fractional exhaled nitric oxide (F ENO) will specifically be examined to determine the time-course and magnitude of the anti-inflammatory effect.
Methods:
A 26-week, open-label, parallel-group, 2-arm, phase IV, two-sided superiority RCT will recruit 180 adults aged 16-75 years with a clinical diagnosis of asthma using reliever only therapy, or SABA reliever therapy with maintenance ICS at baseline, and with baseline F ENO at screening ≥25 ppb. Enrolled participants will be allocated to maintenance budesonide with the dose based on their baseline treatment step and randomised 1:1 to either budesonide-formoterol or terbutaline reliever therapy. All participants will perform at-home F ENO measurements at regular intervals for the first 12 weeks of the study. The primary outcome is F ENO at 26 weeks. Key secondary outcomes include F ENO time-course, asthma exacerbations, asthma control and spirometry.
Conclusion:
This will be the first RCT comparing ICS/formoterol versus SABA reliever therapy in patients who use maintenance ICS therapy.
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