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).
Aged between 18 and 80 years;
Diagnosed with refractory chronic cough or unexplained chronic cough, with a cough lasting for ≥1 year;
Chest CT at screening shows no abnormalities that the investigator believes may lead to chronic cough;
Cough severity VAS score ≥40 mm ;
Currently smoking, or having quit smoking within 12 months prior to screening;
A smoking history of >20 pack-years;
Ongoing exposure to inhaled toxic substances within 12 months prior to screening or currently;
A history of drug abuse or alcoholism (weekly alcohol consumption of 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
Parallel
HW091077
DrugHW091077 oral tablet, oral, QD
HW091077
DrugHW091077 oral tablet, oral, QD
Matching placebo to HW091077
DrugMatching placebo to HW091077 oral tablet, oral, QD
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
