drugset / Trial / NCT02761252

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

NCT02761252 ↗

Phase 4 Completed 454 enrolled Menarini International Operations Luxembourg SA
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2016-04-13
Primary completion
2016-11-24
Completion
2016-11-24

Outcome

Missed primary endpoint

registry analysis (superiority test); Bilastine+Montelukast vs Bilastine Monotherapy; p = 0.5721; Mean Difference (Final Values) -0.194 (95% CI -0.8693 to 0.4813); ANCOVA NCT02761252 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bilastine Small molecule 20 mg Oral
Subject Montelukast Other / unclassified 10 mg Oral