Refractory Chronic CoughPhase 2NCT07483489
A Phase 2 Study of HW091077 in Participants With Refractory Chronic Cough Or Unexplained Chronic Cough (RCC/UCC).
A Phase 2 study testing HW091077 in people with Refractory Chronic Cough, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- HW091077
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
About this study
Official 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).
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
- Being tested
- HW091077, Matching placebo to HW091077
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW091077Drug
HW091077 oral tablet, oral, QD
HW091077Drug
HW091077 oral tablet, oral, QD
Matching placebo to HW091077Drug
Matching placebo to HW091077 oral tablet, oral, QD
| Study group | Role | What they receive |
|---|---|---|
| HW091077 oral dose1 | Experimental | HW091077 oral dose1 once a day. Receives: Drug: HW091077 |
| HW091077 dose2 | Experimental | HW091077 oral dose2 once a day. Receives: Drug: HW091077 |
| placebo | Placebo comparator | Matching Placebo for HW091077 oral dose once a day Receives: Drug: Matching placebo to HW091077 |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-Hour Cough Frequency
Assessed using an ambulatory cough monitor
Measured: at Week 4
Secondary outcomes (2)
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.
Measured: at Week 2 and Week 4
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.
Measured: at Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483489
- Sponsor's protocol ID
- HW091077-201
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT07483489
- Acronym / sponsor ID
- HW091077-201
- Conditions
- Refractory Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HW091077 oral dose1 | Experimental | Drug: HW091077HW091077 oral dose1 once a day. |
| HW091077 dose2 | Experimental | Drug: HW091077HW091077 oral dose2 once a day. |
| placebo | Placebo comparator | Drug: Matching placebo to HW091077Matching Placebo for HW091077 oral dose once a day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HW091077HW091077 oral tablet, oral, QD | Drug | HW091077 dose2 |
| HW091077HW091077 oral tablet, oral, QD | Drug | HW091077 oral dose1 |
| Matching placebo to HW091077Matching placebo to HW091077 oral tablet, oral, QD | Drug | placebo |
Primary outcome
24-Hour Cough Frequency
Time frame: at Week 4
Assessed using an ambulatory cough monitor
2 secondary outcomes
Change from Baseline in Cough Severity Visual Analogue Scale (VAS) at Week 2 and Week 4;
Time frame: at Week 2 and Week 4
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HW091077 in people with Refractory Chronic Cough, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-Hour Cough Frequency (time frame: at Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.