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NCT Number: NCT07483489

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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;

Treatment and study plan

HW091077

Drug

HW091077 oral tablet, oral, QD

Matching placebo to HW091077

Drug

Matching placebo to HW091077 oral tablet, oral, QD

Primary outcomes

  1. 24-Hour Cough Frequency

    Time frame: at Week 4

    Assessed using an ambulatory cough monitor

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: at Week 2 and Week 4

    The LCQ is a patient-reported quality of life (QOL) measure of chronic cough,the higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Industry

Registry information

Official study title

A Randomized,Double-Blind, Multicenter,Placebo-Controlled, Parallel-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of HW091077 in Participants With Refractory Chronic Cough or Unexplained Chronic Cough (RCC/UCC).

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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