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Table 3 Effectiveness studies (RCTs) of ICS/LABA FDC (Review 2): Assessment of identified effectiveness RCT studies

From: Asthma control factors in the Gulf Cooperation Council (GCC) countries and the effectiveness of ICS/LABA fixed dose combinations: a dual rapid literature review

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
  1. ACQ Asthma Control Questionnaire; ACT Asthma Control Test; AHRQ Agency for Healthcare Research and Quality; FDC Fixed-dose combination; FeNO Fractional exhaled nitric oxide; GP General practitioner; ICS Inhaled corticosteroid; ITT Intention-to-treat; LABA Long-acting beta-agonist; RCT Randomised controlled trial; SABA Short-acting beta-agonist