Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis

Summary

ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.

Timeline

Start

2022-08-01

Primary completion

2024-06-05

Completion

2024-06-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo (10 mg Cohort) vs Orvepitant 10 mg; p = 0.989; Mean Difference (Final Values) 0.00 (95% CI -0.62 to 0.63); ANCOVA NCT05185089 ↗

registry analysis (superiority test); Placebo (30 mg Cohort) vs Orvepitant 30 mg; p = 0.054; Mean Difference (Final Values) -0.58 (95% CI -1.16 to 0.01); ANCOVA NCT05185089 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orvepitant	Small molecule	10 mg	—
Subject	Orvepitant	Small molecule	30 mg	—

Indications