A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic … (NCT07483489) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC/UCC).
180 participantsStarted 2026-05-01
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 ;
* Female participants of childbearing potential must have a negative pregnancy test and must not be breastfeeding; male and female participants must have no plans for pregnancy during the entire clinical trial and within 6 months after the last dose, and agree to use medically accepted reliable contraceptive methods during the trial and within 6 months after the last dose;
* Fully understand the study, voluntarily sign the informed consent form, and be able to comply with the study procedures and follow-up requirements.
Exclusion Criteria:
* 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);
* Diagnosed with chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, bronchial asthma (except for cough variant asthma), or other airway/respiratory diseases that may affect coughing;
* Respi…
What they're measuring
1
24-Hour Cough Frequency
Timeframe: at Week 4
Trial details
NCT IDNCT07483489
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.