Refractory chronic cough (RCC)
Conditions
Interventions
HW091077 100mg Group:HW091077 100mg
HW091077 Placebo Group:HW091077 Placebo
HW091077 300mg Group:HW091077 300mg
Sponsors
The First Affliliated Hospital of Guangzhou Medical Universitty
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age range 18 to 80 years (inclusive); 2. Diagnosed with refractory chronic cough or chronic cough of unknown cause, with cough lasting >=1 year; 3. Chest CT at screening did not reveal any abnormalities that the investigator believed could cause chronic cough; 4. During the screening period (Visit 1) and lead-in period (Visit 3), cough severity VAS score >=40mm; 5. During the screening period (Visit 1), cough frequency >=20 times/hour; 6. Female participants of childbearing potential must have a negative pregnancy test and not be breastfeeding; male and female participants must have no pregnancy plans throughout the clinical trial and for 6 months after the last dose, and agree to use medically acceptable reliable contraception during the trial and for 6 months after the last dose; 7. Fully understand the study, voluntarily sign the informed consent form, and be able to follow the study procedures and follow-up examination requirements;
Exclusion criteria
Exclusion criteria: 1. Currently smoking, or having quit smoking within the past 12 months before screening (including all forms of tobacco products such as e-cigarettes, tobacco smoke, nicotine vapour, etc.); 2. Having a smoking index >20 pack-years (smoking index = average daily packs smoked × years of smoking); 3. Continuous exposure to inhaled toxic substances within the past 12 months before screening (e.g., ammonia, chlorine, nitrogen dioxide, phosgene, metalworking dust, etc. 4. History of drug use or alcohol abuse (consuming 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); 5. Diagnosed with chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, sarcoidosis, idiopathic pulmonary fibrosis, bronchial asthma (excluding cough variant asthma) or other airway/respiratory diseases that may affect cough; 6. Respiratory infection or significant change in lung status within the past 4 weeks before screening; 7. Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) =160 mmHg or diastolic blood pressure >=100 mmHg), left ventricular ejection fraction (LVEF) =450 ms, long QT syndrome, etc; 11. Clinically important laboratory test abnormalities, including: • Haematology abnormalities: haemoglobin (Hb) =2×ULN, alanine transaminase (ALT) >=2×ULN, alkaline phosphatase >=2×ULN, or total bilirubin >=2×ULN; • Renal function abnormalities: creatinine (Cr) >=1.5×ULN; • Other laboratory test indicators deemed by the investigator to potentially affect the evaluation of the trial results. 12. Positive for hepatitis B surface antigen, hepatitis C virus antibody/RNA, HIV antibody, or syphilis treponemal antibody; 13. Use of angiotensin-converting enzyme inhibitors (ACEIs) within the past 3 months before screening; 14. Planning to start new RCC/UCC treatment during the trial; 15. Appetite loss/taste disorder within the past month before screening; 6. Non-compliance with induction period medication (120%); 17. Allergy/sensitivity or contraindication to HW091077 tablets or its excipients; 18. Receiving other P2X3 receptor antagonist treatment within the past year before screening; 19. Received other clinical trial drugs within the 4 weeks or 5 half-lives prior to screening (whichever is longer); 20. According to the investigator's judgment, there is any disease, treatment, laboratory abnormality or other condition that may increase the risk associated with the administration of the investigational drug or may interfere with the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 28, change in 24-hour cough frequency from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of AEs and SAEs leading to study withdrawal up to Day 42;Days 14 and 28, the proportion of patients whose cough frequency while awake decreased by =30%, =50% and =70% from baseline;Days 14 and 28, change in VAS score of cough severity compared to baseline;Changes in 12-lead electrocardiogram values from baseline after drug administration;Day 14, change in 24-hour cough frequency from baseline;Days 14 and 28, proportion of patients with a VAS score reduction of =30mm in cough severity;Days 14 and 28, Patient Global Impression of Change (PGIC);Changes in vital signs relative to baseline after drug administration;Days 14 and 28, changes in cough frequency from baseline while awake;Days 14 and 28, proportion of patients with a total LCQ score increase of =1.3 points from baseline;Incidence of study treatment discontinuation due to AE and SAE up to day 42;Changes in laboratory values relative to baseline after administration;Incidence of AE and SAE up to day 42;Days 14 and 28, the proportion of patients whose 24-hour cough frequency decreased by =30%, =50% and =70% from baseline;Days 14 and 28, change in the frequency of night-time cough compared with baseline;Days 14 and 28, changes in Cough Hypersensitivity Questionnaire (CHAT) scores from baseline;Days 14 and 28, changes in LCQ total score from baseline; | — |
Countries
China
Contacts
Public ContactLai Kefang
The First Affliliated Hospital of Guangzhou Medical Universitty
Outcome results
None listed