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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
HRS-2261 oral tablet, oral, BID
Matching placebo to HRS-2261, oral, BID
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28)
Time frame: Baseline (Day-1),Day 28
Changes from baseline in patients' overall Impression of Change (PGIC) scale scores after week 1, 2, 3 and 4 of treatment (Day 7, Day 14, Day 21, Day 28)
Time frame: Day 7, Day 14, Day 21, Day 28
Changes from baseline in the total score of the Leicester Cough Questionnaire (LCQ), which assessed cough-specific quality of life, at 2 and 4 weeks after treatment (Day 14, Day 28)
Time frame: Baseline (Day-1), Day 14, Day 28
Changes from baseline in the simple cough severity score (CET) at week 1, 2, 3, and 4 after treatment (Day 7, Day 14, Day 21, Day 28)
Time frame: Day 7, Day 14, Day 21, Day 28
Incidence and severity of any adverse events (AE)
Time frame: up to 6 weeks (Day 42)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.