NCT02761252

Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

Bilastine and Montelukast in Patients With Seasonal Allergic Rhinoconjunctivitis and Asthma: Efficacy of Concomitant Administration - the SKY Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 454 (actual)
• Sponsor: Menarini International Operations Luxembourg SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma

Detailed description

The present study (SKY) was designed to show if once daily oral combination therapy with Montelukast 10 mg and Bilastine 20 mg is superior to monotherapy with Bilastine 20 mg in patients with Seasonal Allergic RhinoConjunctivitis (SARC) and comorbid mild to moderate asthma on total symptom scores (TSS) and if the combination therapy reflects an improvement in quality of life as assessed via the Asthma Quality of Life Questionnaire (AQLQ) over a longer time period when compared to monotherapies with Montelukast 10 mg and Bilastine 20 mg. Mild to moderate asthma was defined according to the criteria of the Global Initiative for Asthma, i.e., GINA criteria 2 and 3 (GINA, 2012). The study population included patients inadequately controlled on inhaled corticosteroids and in whom "as-needed" short acting beta-agonists provided inadequate clinical control.

Conditions

• Seasonal Allergic Rhinoconjunctivitis
• Asthma

Interventions

Type	Name	Description
DRUG	Bilastine 20mg
DRUG	Montelukast 10mg
DRUG	Placebo Bilastine 20mg
DRUG	Placebo Montelukast 10mg

Timeline

• Start date: 2016-04-13
• Primary completion: 2016-11-24
• Completion: 2016-11-24
• First posted: 2016-05-04
• Last updated: 2019-07-12
• Results posted: 2019-07-12

Locations

32 sites across 8 countries: Croatia, Czechia, Germany, Italy, Latvia, Poland, Romania, Slovakia