No change in lung function seen in with vilanterol vs. placebo in asthma

There was no significant difference in peak expiratory flow change from baseline between vilanterol and placebo among patients with persistent asthma also treated with fluticasone propionate, according to recent data.

Amanda J. Oliver, MBBS, MRCP, FFPM, from GlaxoSmithKline in Middlesex, United Kingdom, and colleagues evaluated 456 children between the ages of 5 years and 11 years with persistent asthma currently taking an inhaled corticosteroid and a short-acting beta agonist as needed. Patients received 100 μg fluticasone propionate twice per day as a replacement for their current asthma treatment and then were randomly assigned to 6.25 μg, 12.5 μg or 25 μg of vilanterol or placebo once per day over 4 weeks. The researchers analyzed forced expiratory volume in 1 second (FEV₁) and change in 24-hour rescue-free and symptom-free periods from baseline, and assessed adverse events and asthma exacerbations.

They found no significant difference in the 25 μg and placebo regarding peak expiratory flow change from baseline. Although there were no significant differences in trough FEV₁ in any vilanterol group, the 25 μg dose showed an increase of 0.6 rescue-free days and 0.7 symptom-free days per week compared with placebo.

Regarding adverse events, Oliver and colleagues found that the vilanterol groups showed a higher (28% to 33%) incidence compared with the placebo group (22%).

“One child in each of the [vilanterol] 6.25 and [vilanterol] 25 groups experienced an [adverse event] leading to study withdrawal. The child in the [vilanterol] 25 treatment group experienced an on-treatment non-fatal serious [adverse event] of appendicitis and the child in the [vilanterol] 6.25 treatment group experienced a viral respiratory tract infection,” Oliver and colleagues wrote in their study. “Neither [adverse event] was judged to be related to study treatment.”

– by Jeff Craven

Disclosure: This study was sponsored by GlaxoSmithKline. Oliver is an employee of and receives stock options from GlaxoSmithKline. Please see the full study for a complete list of all other authors’ disclosures.