PRACTICAL | Novel START | |
Medication at enrolment | As required SABA only OR Regular ICS + as required SABA | As required SABA only |
Intervention (52 weeks) | As required budesonide/formoterol Turbuhaler 200/6 µg (one inhalation) OR Regular budesonide Turbuhaler 200 µg (one inhalation twice daily) plus as required terbutaline 250 µg (two inhalations) | As required salbutamol pMDI 100 µg (two inhalations) OR As required budesonide/formoterol Turbuhaler 200/6 µg (one inhalation) OR Regular budesonide Turbuhaler 200 µg budesonide (one inhalation twice daily) plus as required salbutamol pMDI (two inhalations) |
Electronic monitoring | Substudy of 110 participants | All participants, analysed as part of primary outcome |
Primary outcome | Severe asthma exacerbation rate according to ATS/ERS criteria, expressed as number of severe exacerbations per patient per year | Asthma exacerbation rate expressed as number of exacerbations per patient per year An asthma exacerbation is defined as:
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Withdrawal | Subjects withdrawn from the study if the investigator is concerned about their safety, including need for a medication step-up No automatic exacerbation related withdrawal | Subjects withdrawn from the study if:
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ATS/ERS, American Thoracic Society/European Respiratory Society; ICS, inhaled corticosteroid; SABA, short-acting beta agonist; Novel START, Novel Symbicort Therapy As Reliever Therapy; PRACTICAL, PeRsonalised Asthma Combination Therapy with an Inhaled Corticosteroid And fast-onset Long acting beta agonist; pMDI, pressurised Metered Dose Inhaler.