Lavorini F, Matucci A, Rossi O, Pistolesi M; SKY study investigators.
A double-blind, double-dummy, randomised, active-controlled, parallel group design (The SKY study) compared the efficacy and efficacy of concomitant therapy with bilastine and montelukast with each substance alone in patients with seasonal allergic rhinoconjunctivitis and asthma for four weeks.
419 adults with seasonal allergic rhinoconjunctivitis and mild-to-moderate asthma partially controlled by beclomethasone dipropionate or equivalent were included. They had a forced expiratory volume (FEV1) >70%, a positive skin prick test to one or more allergens and nasal/ocular total symptom score (TSS) >3. Participants were screened for one week and then a twelve weeks treatment.
Allergic rhinoconjunctivitis score (TSS), daytime nasal and non-nasal symptom scores and use of rescue medications were registered.
Contrary to the original hypothesis, concomitant administration of bilastine with montelukast was as effective as either agent alone for allergic rhinoconjunctivitis symptoms, however bilastine alone improved allergic rhinoconjunctivitis symptoms more than montelukast in the first two weeks of treatment.
The SKY study investigators concluded that there is no benefit of using bilastine plus montelukast to provide relief of allergic rhinoconjunctivitis in patients with mild-to-moderate asthma.