Fluticasone Furoate/Vilanterol Reduces Night-Time Awakenings in Asthma Patients

Per data presented at the 2017 American Thoracic Society Conference in Washington D.C. this weekend, patients with night-time symptoms had fewer asthma-related sleep disturbances over time with fluticason furoate (FF)/filanterol (VI).

The addition of VI to FF was most beneficial to the sleep of patients with uncontrolled asthma on a lower level of treatment, and night-time awakenings were improved quicker with FF/VI, than with placebo, FF, or fluticasonepropionate (FP) alone.

Asthma symptoms are known to cause patients to wake up at night, and in turn, affecting their quality of life. The frequency of night-time disturbances that a person experiences is directly indicative of the level of control an asthma patient has over their condition.

In this study, it was speculated that FF/VI would produce an improvement in night-time symptoms and a reduction in night-time awakenings caused by asthma, in comparison to placebo or inhaled corticosteroid (ICS) unaccompanied.

Dairy card data were taken from Phase III studies on patients with asthma, and were randomized, multicenter, double-blind, parallel group-trials has post-hoc analyses, before having post-hoc analyses performed. Being compared were the following:

• FF/VI (100/25 μg OD) vs FF (100μg OD) vs placebo (Bleecker 2014 HZA106827)
• FF/VI (100/25μg OD) vs FF/VI (200/25μg OD) vs FF (100μg OD) (Bernstein 2015, HZA116263)
• FF/VI (200/25μg OD) vs FF (200μg OD) vs FP (500μg twice daily [BD]) (O’Byrne 2014, HZA106829, double-dummy design)

A 0-5 dairy card scale was used in evaluating the severity of symptoms, with 0 defined as “no symptoms during the night,” and 5 defined as “symptoms were so severe that I did not sleep at all.”

Analyses were limited to patients who experienced symptoms on at least one night of the last 7 days of their respective run-in period, and variations in night-time awakenings were based on the following:

• The time taken (days) until 50% of patients first experienced 7 uninterrupted symptom-free nights
• The number of patients who completed 100% symptom free-nights per week
• The number of patients who were symptom-free for more than 50% of nights

Across all studies, the mean age range was 37.8 — 48.2 years, and most the patients were female.

Additionally, odds ratios and 95% confidence intervals (CIs) were calculated for the percentage of patients with greater than or equal to 50% symptom free nights. This was analyzed using a Cox proportional hazards model with covariates of baseline, age, region, sex and treatment.

Overall, it was observed that night-time awakenings improved over time in asthma patients with FF/VI and improved faster with FF/VI as opposed to using FF or placebo.

These studies were funded by GlaxoSmithKline.