This is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HS-10383 in Chinese adult subjects with refractory or unexplained chronic cough (RUCC).
The primary objectives of this study are to evaluate the efficacy of HS-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of HS-10383. The primary hypothesis is that at least one dose of HS-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at Week 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
276
HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
HS-10383 administered as one 50 mg, 100 mg 200 mg tablet once daily, depending upon randomization.
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
Time frame: at Week 4
Awake Cough Frequency
Change from baseline in awake cough frequency at week 4;
Time frame: at Week 4
Change from Baseline in Cough Severity Visual Analogue Scale at Week 2 and Week 4;
Assessed by Cough Severity Visual Analogue Scale \[VAS\] by the participant on a 100 mm visual analog scale where higher scores indicate greater severity.
Time frame: at Week 2 and Week 4
Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4.
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough,the higher scores mean a better outcome.
Time frame: at Week 2 and Week 4
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