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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HW091077 oral dose1 | Experimental | HW091077 oral dose1 once a day. |
|
| HW091077 dose2 | Experimental | HW091077 oral dose2 once a day. |
|
| placebo | Placebo Comparator | Matching Placebo for HW091077 oral dose once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HW091077 | Drug | HW091077 oral tablet, oral, QD |
| |
| HW091077 |
| Measure | Description | Time Frame |
|---|---|---|
| 24-Hour Cough Frequency | Assessed using an ambulatory cough monitor | at Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at Week 2 and Week 4 |
| Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
HW091077 oral tablet, oral, QD |
|
| Matching placebo to HW091077 | Drug | Matching placebo to HW091077 oral tablet, oral, QD |
|
The LCQ is a patient-reported quality of life (QOL) measure of chronic cough,the higher scores mean a better outcome. |
| at Week 2 and Week 4 |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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