A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough (NCT05733533) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough
China97 participantsStarted 2023-03-09
Plain-language summary
This is a phase II study that will investigate the efficacy, safety and tolerability of HRS-2261 in subjects with refractory chronic cough using a double blind, placebo controlled, randomized study design.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥18 years of age;
✓. Diagnosed with refractory chronic cough or chronic cough of unknown cause, with a course of disease lasting more than 1 year;
✓. Within 5 years prior to screening and after the onset of chronic cough, chest imaging did not reveal any significant abnormalities that the investigators considered to cause chronic cough or any other clinically significant lung disease;
✓. VAS scores of cough severity in screening period and baseline period ≥ 40 mm;
✓. Subjects receiving medication for pre-existing underlying conditions prior to the screening period should stabilize the corresponding dose for at least 8 weeks prior to screening;
✓. Take effective contraceptive measures;
✓. Voluntarily sign informed consent to participate in this study;
✓. Willing and able to comply with all protocol requirements, including demonstrating the ability to comply with study procedures prior to random assignment.
Exclusion criteria
✕. Patients diagnosed with chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), and endobronchial tuberculosis;
✕. Patients with a history of chronic bronchitis;
✕. Patients with a history of upper or lower respiratory tract infection, or acute exacerbation of respiratory disease, or significant changes in chest imaging within 4 weeks prior to baseline period;
What they're measuring
1
Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28)
✕. Current smokers, smokers who have quit smoking (within 6 months), or former smokers who consume more than 20 packs of cigarettes per year;
✕. Those with abnormal taste within 3 months prior to previous diagnosis or screening;
✕. Malignant disease within 5 years or less before signing the informed consent, except for basal cell or squamous cell skin cancer or cervical cancer in situ after appropriate treatment;
✕. Currently taking or having taken an angiotensin-converting enzyme inhibitor in the 3 months prior to screening;
✕. Those who are currently taking or have used any antitussive medication within the week prior to screening;