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

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People who have mild-moderate asthma are traditionally treated with a short-acting beta-agonist (SABA) for symptom relief, with or without daily low dose inhaled corticosteroids (ICS). However, even when ICS are prescribed, most patients have poor compliance, despite education. One potential approach which addresses this problem inherent in ICS-based maintenance treatment is to combine an ICS in the beta2-agonist reliever inhaler, thereby ensuring that the patient receives a dose of ICS whenever they use their bronchodilator. Switching the relief inhaler from a SABA to a combined ICS-formoterol inhaler so that patients receive ICS each time they use their relief inhaler could potentially reduce airways inflammation, improve asthma control and reduce the risk of asthma attacks. We therefore plan to determine the clinical benefit of replacing a SABA with an ICS-formoterol inhaler in patients with mild-moderate asthma, who also receive a low or medium dose ICS as maintenance treatment. This proposed RCT should provide the evidence on which this approach can be considered for use in clinical practice. If confirmed to be effective, this simple change to asthma management could markedly improve overall asthma control and reduce exacerbations and potentially reduce deaths from asthma. The FeNO has been chosen as the primary outcome measure as it is a validated biological marker of airways inflammation in asthma. We hypothesise that In adults aged 16 to 75 with mild-moderate asthma, as-needed budesonide-formoterol (Symbicort Turbuhaler) for symptom relief will lead to reduced airways inflammation compared with terbutaline (Bricanyl Turbuhaler) reliever therapy, on a background of maintenance ICS therapy.