|
| Study/year | Country | No. of subjects (n) | Design | Outcome |
|
| Studies comparing switch in therapy of FF with salmeterol-fluticasone |
| Usmani et al. [25] | England | 225 | A randomized, controlled, pragmatic, open-label trial on well-controlled asthmatic patients | In patients with well-controlled asthma, a change from fluticasone-salmeterol to FF did not compromise asthma control. Step down of FF was well tolerated |
| Simon et al. [26] | The UK | 2472 | A historical, matched cohort database study evaluated two treatment groups in the Optimum Patient Care Research Database in the UK | Changing to, or initiating FF combination therapy, is associated with a noninferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with fluticasone-salmeterol |
|
| Long-term real-world studies of efficacy and safety |
| Backer et al. [22] | Czech republic, Denmark, France, Ireland, Norway, Slovak Republic, Sweden, and the United Kingdom | 2539 | A 12-month observational study of outpatients with asthma | In this real-world postauthorization safety study, FF demonstrated a safety profile consistent with that seen in controlled clinical trials |
| Price et al. [23]/2019 | The UK | 41,609 | A historical, longitudinal cohort database study using UK primary care data from the Clinical Practice Research Datalink (CPRD) database | FF was associated with an overall lower adverse outcome rate |
| Mansur et al. [24] | Germany, Hungary, Poland, Romania, and the United Kingdom | 413 | An open-label study, mild to moderate-severe asthmatics | FF had a good safety and efficacy profile over the 6- and 12-month study periods |
|
| Budget impact analysis of FF |
| Emily et al. [27] | The United Kingdom | — | Real-world analysis | The use of FF as an alternative to fluticasone-salmeterol can result in cost savings for the NHS when assessing drug |
| Dunlop et al. [28] | The United Kingdom | — | Real-world analysis | The comparable efficacy and lower acquisition costs of FF compared with fluticasone-salmeterol make it a cost-saving option for the UK NHS for the treatment of asthma patients requiring combination maintenance therapy using a pMDI |
|
| Studies on FF using specialized inhalation devices |
| Ghoshal et al. [29] | India | 385 | A prospective, open-label, noncomparative, real-world observational, 24-week, multicenter study | FF FDC capsules administered via a single-dose DPI, (Revolizer®) offer a novel, well-tolerated, and effective treatment option for the long-term management of asthma |
| Bell et al. [30] | The United Kingdom | 307 | A randomized, open-label, two-period, crossover study | Ease of use and preference data for FF pMDI challenged the perceived wisdom that DPI are necessarily simpler to use, whereas the corresponding data for FF K-haler strongly favoured this novel BTI over the Turbuhaler, Accuhaler, and other pMDIs |
|
