Once-Daily FF/VI Matches Twice-Daily ICS/LABA in Asthma Control

Philippe Devillier, MD

A once-daily dose of fluticasone furoate/vilanterol (FF/VI) relieves uncontrolled asthma just as well as a twice-daily dose of a combination inhaled corticosteroids and long-acting beta-agonists (ICS/LABA), according to a recently published study.

About half of all adults with asthma between 2006 and 2010 had uncontrolled symptoms, according to the US Centers for Disease Control and Prevention (CDC). For as debilitating as the effects can be to a patient with asthma, uncontrolled symptoms exacts another toll on the healthcare system; it increases emergency department (ED) visits, hospitalizations, and contributes to work and school absenteeism in affected patients.

The currently recommended treatment for persistent asthma is a daily dose of ICS, with patients that still struggle with asthma control being prescribed combination ICS/LABA. Researchers sought to test the efficacy and safety of both doses of once-daily FF/VI and twice-daily ICS/LABA as maintenance therapy. They noted that a reduction in the frequency of medication regimen has been proven to aid adherence, and thus hypothesized that if compliance with dosage is improved, asthma control is also improved.

Between July 9, 2015 and July 10, 2017, 423 primary and secondary care patients in Germany and France were enrolled to randomly receive either FF/VI (100/25 or 200/25mg) or twice-daily fixed combinations of ICS/LABA (fluticasone proprionate/salmeterol or budesonide/formoterol) over the treatment span of 6 months.

Qualifying patients had physician-diagnosed asthma, had been receiving ICS alone as their maintenance therapy for more than 4 weeks, and had an Asthma Control Test (ACT) score between 15 and 20. Patients were excluded if they had a life-threatening history of asthma, severe or unstable asthma, COPD, current of former cigarette smokers, or a history of adverse reactions to corticosteroid and LABA therapy.

Researchers noted that patients were all stepped up to ICS/LABA prior to randomization. Population differences may have impacted on the results, however, as patients with more severe asthma — with greater potential for improvement in asthma control — were excluded from the study.

Results showed the change in total ACT scores at week 12 was 3.6 units improved with FF/VI and 2.8 units improved with ICS/LABA, a treatment difference of 0.8 (95% CI; 0.1 - 1.5; P = 0.033). By week 6, patients receiving once-daily FF/VI were reporting similar asthma control to those receiving twice-daily ICS/LABA.

Study co-author, Philippe Devillier, MD, a professor at University of Paris-Saclay, told MD Mag that the efficacy of FF/VI was demonstrated in patients with stable but unsatisfactorily controlled asthma.

“However, the current study is not a real-world study because the study drug is provided by researchers, there is more frequent contact with patients, and the adherence to medication and correct use of devices is monitored and assessed,” Devillier said.

Researchers noted that more than 93% of the participating patients had used their inhalers without error — either critical or non-critical. The rate is significantly high for correct inhaler use among patients with asthma, and likely due to the physician-to-patient training provided at randomization. But that influence may have added to the control of trial results.

Devillier suggested that further studies should explore once-daily dosing in asthmatic populations where uncontrolled symptoms are related to poor adherence.

The study, “Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial,” was published online in Respiratory Medicine.