A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05599191Tipo: INTERVENTIONALInicio: 25 de oct de 2022Fin estimado: 28 de may de 2026

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Capable of giving signed informed consent
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

Intervenciones

drug

BLU-5937

Oral administration of BLU-5937 Tablets

drug

Placebo

Oral administration of matching placebo for BLU-5937 Tablets

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Mar del Plata, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Miguel de Tucumán, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Vicente López, Argentina

Patrocinadores

PrincipalBellus Health Inc. - a GSK company

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