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Fluticasone furoate + vilanterol superior to usual care in improving asthma control

Roshini Claire Anthony
21 Sep 2017

Initiating therapy with fluticasone furoate plus vilanterol resulted in improved asthma control over usual care in individuals with symptomatic asthma, according to results of the Salford Lung Study presented at ERS 2017.

“[T]his is the first time the [fluticasone furoate plus vilanterol] combination has shown additional benefits, in terms of asthma control, when compared with optimized usual care in a broad patient population,” said the researchers.

Patients aged ≥18 years (n=4,233, mean age 50 years, 59 percent female) from 74 GP clinics in Salford and South Manchester, UK, with GP-diagnosed symptomatic asthma and on maintenance therapy (inhaled corticosteroids with or without a long-acting β-agonist) were randomized to receive once-daily inhaled doses of fluticasone furoate (100 or 200 µg) plus vilanterol (25 µg, n=2,114) or optimized usual care (n=2,119) and were followed up for 12 months.

The primary effectiveness analysis population consisted of patients with ACT score <20 at baseline; 1,207 patients with scores ≥20 (602 and 605 in the fluticasone furoate plus vilanterol and usual care groups, respectively) were thus excluded from the primary analysis. Patients who had been randomized to fluticasone furoate plus vilanterol could add on or replace this treatment with other asthma medications while those randomized to usual care could change to other medications except for fluticasone furoate plus vilanterol. Twenty-two and 18 percent of patients on fluticasone furoate plus vilanterol and usual care, respectively, changed medications.

In the primary effectiveness analysis population, at 24 weeks, patients assigned to fluticasone furoate plus vilanterol had a higher likelihood of being responders (asthma control test [ACT] score ≥20 or increase by ≥3 points from baseline) compared with patients on usual care (71 percent vs 56 percent; odds ratio [OR], 2.00, 95 percent confidence interval [CI], 1.70–2.34; p<0.0001). These findings were sustained throughout the follow-up period (OR, 2.04, 1.77, and 1.83 at weeks 12, 40, and 52, respectively; p<0.0001 for all). [Lancet 2017;doi:10.1016/S0140-6736(17)32397-8; ERS 2017, abstract OA 3193]

The findings were similar in the analysis of the total population at week 24 (74 percent vs 60 percent; OR, 1.97, 95 percent CI, 1.71–2.26; p<0.0001).

Mean ACT score in the primary analysis population at 24 weeks was also more elevated in patients on fluticasone furoate plus vilanterol compared with those on usual care (mean increase from baseline, 4.4 vs 2.8; difference, 1.6, 95 percent CI, 1.3–2.0; p<0.0001), while adjusted annual exacerbation rate did not significantly differ between groups (p=0.6969).

“[O]ur data suggest that there are other important factors underlying asthma exacerbations in the everyday care setting, which are independent of asthma control and not present in a tightly controlled efficacy trial,” said the researchers.  

When accounting for treatment modification, incidence of pneumonia was low and comparable between groups; however, according to randomized group, pneumonia incidence was higher among patients assigned to fluticasone furoate plus vilanterol compared with usual care (n=23 vs 16).

The researchers acknowledged that the open-label design may have affected the results and highlighted the role of effectiveness trials in routine care in influencing clinical guidelines for chronic diseases.

“Embedded within a primary care setting, [this trial] assesses important patient outcomes by use of the existing electronic health record … [it] gives estimates of what might be expected to happen when you treat the next patient with asthma in your clinic,” said Professor Peter Gibson from the John Hunter Hospital, New South Wales, Australia, in a commentary. [Lancet 2017;doi:10.1016/S0140-6736(17)32398-X]

 

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Most Read Articles
22 May 2017
Chronic obstructive pulmonary disease (COPD) is currently the 10th commonest cause of death in Singapore, with a disease burden of 5.9 percent according to a 2015 population-based survey (EPIC-Asia survey) in Singapore. Pearl Toh spoke with Dr Augustine Tee, chief and senior consultant of the Department of Respiratory and Critical Care Medicine at Changi General Hospital (CGH) in Singapore, on how COPD is often underdetected in the primary care population as symptoms are not specific and diagnosis requires a combination of clinical risk factors, symptoms and spirometry testing.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
04 Aug 2017
Chronic obstructive pulmonary disease (COPD) is the fourth cause of global mortality, with experts predicting a potential future rise in the prevalence rates of COPD. 
11 May 2016

In conjunction with World Asthma Day which falls on 3rd May 2016, MIMS Doctor speaks to a renowned respiratory medicine specialist, Dato' Dr. Hj Abdul Razak Abdul Muttalif, regarding the chronic airway disease.