A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC/UCC).

NCT07483489 | Not Yet Recruiting Phase 2

• 1 other identifier: HW091077-201
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Refractory Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 24-Hour Cough Frequency

  Assessed using an ambulatory cough monitor

  at Week 4

Secondary Outcomes (2)

• Change from Baseline in Cough Severity Visual Analogue Scale (VAS) at Week 2 and Week 4;

  at Week 2 and Week 4

• Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 2 and Week 4.

  at Week 2 and Week 4

Study Arms (3)

HW091077 oral dose1

EXPERIMENTAL

HW091077 oral dose1 once a day.

Drug: HW091077

HW091077 dose2

EXPERIMENTAL

HW091077 oral dose2 once a day.

Drug: HW091077

placebo

PLACEBO COMPARATOR

Matching Placebo for HW091077 oral dose once a day

Drug: Matching placebo to HW091077

Interventions

HW091077 DRUG

HW091077 oral tablet, oral, QD

HW091077 dose2

Matching placebo to HW091077 DRUG

Matching placebo to HW091077 oral tablet, oral, QD

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Respiratory tract infection or significant changes in lung status within 4 weeks prior to screening;
• FEV1/FVC)\<60%;
• Clinically significant electrocardiogram abnormalities, such as QTc interval ≥450 ms, long QT syndrome, etc.;
• Use of angiotensin-converting enzyme inhibitors (ACEIs) within 3 months prior to screening;
• Plans to initiate new treatment for RCC/UCC during the trial period;
• Taste disturbance within 1 month prior to screening;
• Use of any P2X3 receptor antagonist within 1 year prior to screening;

Sponsors & Collaborators

• Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.: lead

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03