This is a randomized, multicenter, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of HW091077 in Chinese adult subjects with refractory chronic cough or unexplained chronic cough (RCC/UCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
Time frame: at Week 4
Change from Baseline in Cough Severity Visual Analogue Scale (VAS) 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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