Resumen

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

Age: 18 Years to 80 Years old

Género: Todos

Fecha de inicio: 10/25/2022

Fecha de finalización principal (estimada): 12/18/2025

Fecha estimada de finalización del estudio: 05/28/2026

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

The primary efficacy objective is to assess the effect of BLU-5937 on 24-hour cough frequency in adults with refractory chronic cough (including unexplained chronic cough) at 12 weeks.

Criterios de elegibilidad

Age: 18 Years to 80 Years old

Género: Todos

Acepta voluntarios sanos: No

Criterios de inclusión:

* Capaz de dar su consentimiento informado por escrito.

* Refractory chronic cough (including unexplained chronic cough) for at least one year

* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose

Criterios de exclusión:

* Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history

* Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment

* Respiratory tract infection within 4 weeks before screening

* Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening

* History of malignancy in the last 5 years

* History of alcohol or drug abuse within the last 3 years

* Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.

* Previous participation in a BLU-5937 trial