Table 3

Comparison of the PRACTICAL and Novel START trial designs

PRACTICALNovel START
Medication at enrolmentAs 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 monitoringSubstudy of 110 participantsAll participants, analysed as part of primary outcome
Primary outcomeSevere asthma exacerbation rate according to ATS/ERS criteria, expressed as number of severe exacerbations per patient per yearAsthma exacerbation rate expressed as number of exacerbations per patient per year An asthma exacerbation is defined as:

  • Worsening asthma resulting in urgent medical review (primary care visit, ED visit or hospital admission) AND/OR

  • Worsening asthma resulting in use of systemic corticosteroids, such as a course of prednisone for any duration AND/OR

  • Worsening asthma resulting in a high beta agonist use episode, defined as >16 actuations of salbutamol or >8 actuations over a 24-hour period

WithdrawalSubjects withdrawn from the study if the investigator is concerned about their safety, including need for a medication step-up
No automatic exacerbation related withdrawal		Subjects withdrawn from the study if:

  • The investigator is concerned about their safety.

  • They have three exacerbations (as per criteria above).

  • They have one severe exacerbation defined by ATS/ERS criteria.27

  • 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.