Table 3 Effectiveness studies (RCTs) of ICS/LABA FDC (Review 2): Assessment of identified effectiveness RCT studies
Effectiveness RCTs | ICS/LABA FDC interventions | Primary care setting? | Broadness of eligibility criteria | Duration | Sample size calculation [sample size, n] | Asthma control? | Safety measure? | ITT population? |
|---|---|---|---|---|---|---|---|---|
Usmani et al. 2017 [40] [NCT02388373] | Fluticasone propionate /formoterol vs fluticasone propionate /salmeterol | YES [general practice] | Control or partially controlled with prescription for at least 6 months with no exacerbation in the 3 months prior to enrolment | 24 weeks | YES [225] | YES [ACQ7] | YES [Adverse events] | YES [Not as initially planned] |
Woodcock et al. 2017 [41] [NCT01706198] | Fluticasone furoate/vilanterol vs usual care including ICS/LABA FDC | YES [general practice] | GPs’ diagnosis of symptomatic asthma and on maintenance inhaler therapy | 52 weeks | YES [4233] | YES [ACT] | YES [Adverse events] | YES |
Aubier et al. 2010 [42] [NCT00463866] | Two budesonide/formoterol maintenance doses | Not indicated | Moderate-to-severe asthma who were symptomatic despite daily use of an ICS with or without LABA | 6 months | YES [8424] | NO [Time to severe exacerbation] | YES [Adverse events] | Not Indicated |
Beasley et al. 2019 [43] [ACTRN12615000999538] | Budesonide/formoterol 200 μg/6 μg as needed compared to budesonide (200 μg, one inhalation twice daily) plus as needed albuterol or as needed albuterol | No [primary and secondary care] | Self-reported doctor diagnosis of asthma and use of a SABA as the sole asthma therapy in the previous 3 months on ≥2 occasions, but on an average of ≤2 occasions per day, in the previous 4 weeks | 52 weeks | YES [675] | YES [ACQ5] | YES [Adverse events] | YES |
Hardy et al. 2019 [44] [ACTRN12616000377437] | Budesonide/formoterol 200 μg/6 μg reliever therapy compared to maintenance budesonide plus terbutaline | No [primary care or hospital-based clinical trials units and primary care practices] | Self-reported doctor diagnosis of asthma and taking either SABA reliever therapy alone or SABA plus low to moderate dose ICS in the 12 weeks before randomisation | 52 weeks | YES [890] | YES [ACQ5] | YES [Adverse events] | YES |
Hozawa et al. 2014 [45] | Budesonide/formoterol for maintenance and reliever therapy and fluticasone propionate/salmeterol | No [outpatient] | Inadequately controlled asthma patients treated with a medium dose of ICS alone and using a SABA 2–6 occasions/ week | 8 weeks | Not Indicated [30] | NO [change in FeNO] | YES [Adverse events] | NO |