A new study published in The Lancet shows that once-daily inhalation of a powder, made up of drugs fluticasone furoate and 25mg Vilanterol (FF/VI), was conspicuously more effective than taking regular maintenance inhaler therapy alone.at improving scores in a specified test of asthma control– the Asthma Control Test (ACT).
The study is significant as evidence of management of asthma with the drug of trial compared with their usual care was closely monitored in a randomised trial which simulated usual clinical practice
Prof Ashley Woodcock et al. conducted an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy.The patients were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle.
The study showed that a once-daily inhalation of a powder, made up of drugs fluticasone furoate and 25mg Vilanterol (FF/VI), was conspicuously more effective at improving scores in a test of asthma control, using a validated tool – the Asthma Control Test (ACT), than taking regular maintenance inhaler therapy alone.
Regular maintenance inhaler therapy is defined as taking inhaled corticosteroids (ICS) on their own, or in combination with a long-acting beta-agonist (LABA).
Out of 4,233 patients for the study, the drug fluticasone furoate and vilanterol were given to 2,114 patients and 2119 patients were given usual care and results were monitored at 12, 24, 40 and 52 weeks.
It was found that at 24 weeks, a significantly higher percentage of patients with symptomatic asthma and initiated on treatment with fluticasone furoate and vilanterol achieved better control of their asthma (71%), compared with patients continuing usual care treatment (56%), This result was consistent for the duration of the study and statistically significant findings were also seen at 12, 40 and 52 weeks.
The ACT is used globally in asthma management and referenced in treatment guidelines to assess asthma control, and takes into consideration aspects such as how often patients use an intervention inhaler, and whether they have any time off work with asthma symptoms.
It is self-administered utilizing five questions to assess asthma control during the past four weeks on a five-point categorical scale (1 to 5). By answering all five questions, a patient with asthma can obtain a score that may range between five and 25, with higher scores indicating better control.
The authors concluded that in patients with a general practitioner’s diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care.
The full study is titled “Effectiveness of Fluticasone Furoate / Vilanterol in Asthma in clinical practice and can be read in detail at