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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2261 oral tablet | Experimental |
| |
| Matching placebo to HRS-2261 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2261 oral tablet | Drug | HRS-2261 oral tablet, oral, BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28) | Baseline (Day-1),Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| Matching placebo to HRS-2261 |
| Drug |
Matching placebo to HRS-2261, oral, BID |
|
| 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) | Day 7, Day 14, Day 21, Day 28 |
| Incidence and severity of any adverse events (AE) | up to 6 weeks (Day 42) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |