New research published in the Journal of Asthma found that combination therapy with fluticasone furoate (FF) and vilanterol (VI) reduced daytime and nighttime symptoms in patients with persistent uncontrolled asthma compared with FF monotherapy or placebo.1
Among the challenges faced by individuals with asthma, nighttime symptoms impair sleep quality and subsequently reduce quality of life.2 Although global treatment guidelines indicate that patients who experience any waking night because of such symptoms in the last 4 weeks are considered to have asthma that is not well-controlled, research on nighttime waking as an aspect of asthma control is lacking.3
In 3 previous phase 3 randomized controlled trials, a once-daily dose of FF/VI was found to improve lung function and exacerbations in 2234 patients with uncontrolled persistent asthma who were using inhaled corticosteroids (ICS) ± long-acting beta2-agonists at baseline.4-6
In the present study, the researchers conducted post hoc analyses of those trials, in which the original researchers had analyzed combined data on daytime and nighttime symptoms to compare the effects of FF/VI 100/25 µg and 200/25 µg with those of FF monotherapy, fluticasone propionate monotherapy (FP), and placebo. The current researchers considered daytime and nighttime symptoms separately to determine the effects of FF/VI on each type.
Patients used an eDiary to report daytime and nighttime symptoms each night and morning before administering any medication. Daytime asthma symptoms were rated on a scale of 0 to 5 (0=no daytime symptoms, 5=symptoms so severe that they interfered with work or usual daily activities), and nighttime symptoms were rated on a scale of 0-4 (0=no nighttime symptoms, 4=symptoms so severe that the patient was unable to sleep at all). End points included change from baseline in the percentage of symptom-free days and nights, proportion of patients reporting 100% symptom-free nights for each week during the treatment period, and number of days it took for patients to achieve 7 consecutive symptom-free nights.
Results showed that all treatments were associated with improvements in symptom-free days and nights, with specific findings as follows:
- A greater number of patients in the FF/VI groups experienced 100% symptom-free nights during the last week of treatment compared with patients who received placebo or other treatments. For instance, 48% of patients who received FF/VI 100/25 µg vs 37% of patients who received FF monotherapy in 1 of the trials
- FF/VI was shown to decrease time until 7 consecutive symptom-free nights. In 1 study, for example, 50% of patients achieved this outcome in 44 days with FF/VI 100/25 µg vs 70 days with FF 100 µg
- Patients who had reported at least 1 symptomatic night at baseline reported an additional 2.7 and 2.0 symptom-free nights per week with FF/VI 100/25 µg vs 1.9 and 1.7 with FF only, and similar results were observed with FF/VI 200/25 µg.
“The addition of VI to FF was observed to confer the greatest benefit on night-time awakenings for patients with uncontrolled asthma who were receiving a lower level of treatment at the time of study entry,” the researchers noted. “Given the accepted impact of night-time awakenings on patient sleep and daily functioning, it may be worth assessing the effect of treatment with FF/VI on these parameters.”
The 3 trials and the current post hoc analyses were funded by GlaxoSmithKline, and 6 of the 7 authors are GlaxoSmithKline employees. In addition, Dr Kerwin reports various fees for consulting and other roles with various pharmaceutical companies.
- Kerwin E, Barnes N, Gibbs M, et al. Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms; post-hoc analyses of three randomized controlled trials [published online August 7, 2017]. J Asthma. doi:10.1080/02770903.2017.1362429
- Sanz de Burgoa V, Rejas J, Ojeda P; for the investigators of the Coste Asma study. Self-perceived sleep quality and quantity in adults with asthma: findings from the CosteAsma study. J Investig Allergol Clin Immunol. 2016;26(4):256-262.
- Global Initiative for Asthma (GINA). 2016 GINA Report, global strategy for asthma management and prevention. http://ginasthma.org/wp-content/uploads/2016/04/GINA-2016-main-report_tracked.pdf. Accessed August 29, 2017.
- Bleecker ER, Lötvall J2, O’Byrne PM, et al. Fluticasone furoate-vilanterol 100-25 mcg compared with fluticasone furoate 100 mcg in asthma: a randomized trial. J Allergy Clin Immunol Pract. 2014;2(5):553-561.
- O’Byrne PM, Bleecker ER, Bateman ED, et al. Once-daily fluticasone furoate alone or combined with vilanterol in persistent asthma. Eur Respir J. 2014;43(3):773-782.
- Bernstein DI, Bateman ED, Woodcock A, Toler WT, Forth R, Jacques L, et al. Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma. J Asthma. 2015;52(10):1073-1083.