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drugset / Trial / NCT03979638

A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough

NCT03979638 ↗

Phase 2 Terminated 68 enrolled Bellus Health Inc. - a GSK company
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough

Timeline

Start
2019-07-10
Primary completion
2020-04-23
Completion
2020-04-23

Outcome

Missed primary endpoint

Stopped (Enrollment): “Trial was terminated due to the impact of the COVID-19 on trial activities. 68 patients with refractory chronic cough were enrolled with 52 completing treatment”

registry analysis (superiority test); BLU-5937 - 25 mg vs Placebo Comparator - 25 mg; p = 0.1424; NCT03979638 ↗

registry analysis (superiority test); BLU-5937 - 50 mg vs Placebo Comparator - 50 mg; p = 0.4602; NCT03979638 ↗

registry analysis (superiority test); BLU-5937 - 100 mg vs Placebo Comparator - 100 mg; p = 0.4181; NCT03979638 ↗

registry analysis (superiority test); BLU-5937 - 200 mg vs Placebo Comparator - 200 mg; p = 0.0855; NCT03979638 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Camlipixant Small molecule 25 mg Oral
Subject Camlipixant Small molecule 50 mg Oral
Subject Camlipixant Small molecule 100 mg Oral
Subject Camlipixant Small molecule 200 mg Oral

Indications

No indication recorded.