A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension

Официальное название

A Phase 3, 24-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-2) - China Extension

Обзор

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

Подробное описание

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 24 weeks.

Вмешательства

• Препарат BLU-5937
  Oral administration of BLU-5937 Tablets.
• Препарат Placebo
  Oral administration of matching placebo for BLU-5937 Tablets.

Первичные конечные точки

• 24-Hour Cough Frequency [Срок оценки: Week 24]
• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24 [Срок оценки: Up to Week 24]
• Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24 [Срок оценки: Up to Week 24]
• Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24 [Срок оценки: Up to Week 24]
• Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24 [Срок оценки: Up to Week 24]
• Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24 [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (8)

• Change from Baseline in Cough Severity Visual Analogue Scale at Week 24 [Срок оценки: Baseline, Week 24]
• Percentage of Participants With Greater than or Equal to (>=) 30 mm Reduction From Baseline in Cough Severity Visual Analog Scale at Week 24 [Срок оценки: Baseline, Week 24]
• Awake Cough Frequency at Week 24 [Срок оценки: Week 24]
• Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24 [Срок оценки: Baseline, Week 24]
• Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24 [Срок оценки: Baseline, Week 24]
• Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24 [Срок оценки: Baseline, Week 24]
• Percentage of Participants with CCD Response at Week 24 [Срок оценки: Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 38 центров

• GSK Investigational Site — Leshan
• GSK Investigational Site — Пекин
• GSK Investigational Site — Чанша
• GSK Investigational Site — Чэнду
• GSK Investigational Site — Чэнду
• GSK Investigational Site — Чунцин
• GSK Investigational Site — Дунгуань
• GSK Investigational Site — Ganzhou
• … и ещё 30 центров

Идентификаторы

NCT: NCT07650084 · 221851-CHN · BUS-P3-02,

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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