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Recruiting NCT07650084

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

Phase III Interventional Refractory Chronic Cough

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BLU-5937, Placebo.
Who it may be relevant to
Registry conditions: Refractory Chronic Cough. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

  • 24-Hour Cough Frequency [Time frame: Week 24]
  • Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24 [Time frame: Up to Week 24]
  • Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24 [Time frame: Up to Week 24]
  • Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24 [Time frame: Up to Week 24]
  • Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24 [Time frame: Up to Week 24]
  • Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24 [Time frame: Baseline, Week 24]
Secondary outcome measures (8)
  • Change from Baseline in Cough Severity Visual Analogue Scale at Week 24 [Time frame: 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 [Time frame: Baseline, Week 24]
  • Awake Cough Frequency at Week 24 [Time frame: Week 24]
  • Percentage of Participants With >= 30 percent (%) Reduction From Baseline in 24-Hour Cough Frequency at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 24 [Time frame: Baseline, Week 24]
  • Percentage of Participants With a >= 1.3-point Increase From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Week 24 [Time frame: Baseline, Week 24]
  • Change from Baseline in the Chronic Cough Diary (CCD) Score at Week 24 [Time frame: Baseline, Week 24]
  • Percentage of Participants with CCD Response at Week 24 [Time frame: Week 24]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 38 centers
  • GSK Investigational Site — Leshan
  • GSK Investigational Site — Beijing
  • GSK Investigational Site — Changsha
  • GSK Investigational Site — Chengdu
  • GSK Investigational Site — Chengdu
  • GSK Investigational Site — Chongqing
  • GSK Investigational Site — Dongguan
  • GSK Investigational Site — Ganzhou
  • … and 30 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗