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Not yet recruitingNCT07483489Updated Mar 19, 2026

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

A Phase 2 interventional study of HW091077 and HW091077 in Refractory Chronic Cough, sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Refractory Chronic Cough

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03

In context

Chronic Cough

140 studies on the registry are indexed under Chronic Cough; 37 are open to participants now.

This study's planned enrollment of 180 is above the median of 56 across 105 interventional studies indexed under Chronic Cough.

Browse Chronic Cough studies →

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. is the lead sponsor of 8 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    HW091077 oral dose1

    HW091077 oral dose1 once a day.

    Drug: HW091077

  • Experimental
    HW091077 dose2

    HW091077 oral dose2 once a day.

    Drug: HW091077

  • Placebo comparator
    placebo

    Matching Placebo for HW091077 oral dose once a day

    Drug: Matching placebo to HW091077

Interventions

  • DrugHW091077

    HW091077 oral tablet, oral, QD

  • DrugHW091077

    HW091077 oral tablet, oral, QD

  • DrugMatching placebo to HW091077

    Matching placebo to HW091077 oral tablet, oral, QD

06

What researchers measure

Primary outcomes

  1. 24-Hour Cough Frequency

    Assessed using an ambulatory cough monitor

    Time frame: at Week 4

Secondary outcomes

  1. Change from Baseline in Cough Severity Visual Analogue Scale (VAS) 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.

    Time frame: at Week 2 and Week 4

  2. Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Score 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.

    Time frame: at Week 2 and Week 4

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07483489
Lead sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Responsible party
Sponsor
First posted
Mar 19, 2026
Start date
May 1, 2026 (estimated)
Primary completion
Aug 30, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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