Refractory Chronic CoughPhase 2NCT05733533
A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough
A Phase 2 study testing HRS-2261 oral tablet in people with Refractory Chronic Cough, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a phase II study that will investigate the efficacy, safety and tolerability of HRS-2261 in subjects with refractory chronic cough using a double blind, placebo controlled, randomized study design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- HRS-2261 oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2023to 5 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- Diagnosed with refractory chronic cough or chronic cough of unknown cause, with a course of disease lasting more than 1 year;
- Within 5 years prior to screening and after the onset of chronic cough, chest imaging did not reveal any significant abnormalities that the investigators considered to cause chronic cough or any other clinically significant lung disease;
- VAS scores of cough severity in screening period and baseline period ≥ 40 mm;
- Subjects receiving medication for pre-existing underlying conditions prior to the screening period should stabilize the corresponding dose for at least 8 weeks prior to screening;
- Take effective contraceptive measures;
- Voluntarily sign informed consent to participate in this study;
- Willing and able to comply with all protocol requirements, including demonstrating the ability to comply with study procedures prior to random assignment.
Who cannot join
- Patients diagnosed with chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), and endobronchial tuberculosis;
- Patients with a history of chronic bronchitis;
- Patients with a history of upper or lower respiratory tract infection, or acute exacerbation of respiratory disease, or significant changes in chest imaging within 4 weeks prior to baseline period;
- Current smokers, smokers who have quit smoking (within 6 months), or former smokers who consume more than 20 packs of cigarettes per year;
- Those with abnormal taste within 3 months prior to previous diagnosis or screening;
- Malignant disease within 5 years or less before signing the informed consent, except for basal cell or squamous cell skin cancer or cervical cancer in situ after appropriate treatment;
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- Currently taking or having taken an angiotensin-converting enzyme inhibitor in the 3 months prior to screening;
- Those who are currently taking or have used any antitussive medication within the week prior to screening;
- Patients who had used oral steroids or antiallergy drugs within 1 week prior to screening;
- Screening or baseline 1 second rate < 60%;
- Poorly controlled hypertension;
- Alanine aminotransferase or aspartate aminotransferase more than 2 times the upper limit of normal in screening period or baseline period;
- Estimated glomerular filtration rate (eGFR) < 30mL/min/1.73m2 or eGFR≥30mL/min/1.73m2 and <50mL/min/1.73m2 with unstable renal function during screening;
- Use of systemic immunosuppressants or immunomodulators, or biologics or Th2 cytokine inhibitors within 12 weeks prior to randomization or within 5 half-lives of the drug;
- A recent history of drug or alcohol abuse or dependence (within the past 1 year);
- Participants enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of test drugs before screening, whichever is longer;
- Any past or present circumstances, determined by the investigator or sponsor, make the subject unfit for admission to the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study of Efficacy and Safety of HRS-2261 in Refractory Chronic Cough
This is a phase II study that will investigate the efficacy, safety and tolerability of HRS-2261 in subjects with refractory chronic cough using a double blind, placebo controlled, randomized study design.
- Conditions
- Refractory Chronic Cough
- Being tested
- HRS-2261 oral tablet, Matching placebo to HRS-2261
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-2261 oral tabletDrug
HRS-2261 oral tablet, oral, BID
Matching placebo to HRS-2261Drug
Matching placebo to HRS-2261, oral, BID
| Study group | Role | What they receive |
|---|---|---|
| HRS-2261 oral tablet | Experimental | Not described Receives: Drug: HRS-2261 oral tablet |
| Matching placebo to HRS-2261 | Placebo comparator | Not described Receives: Drug: Matching placebo to HRS-2261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28)
Measured: Baseline (Day-1)，Day 28
Secondary outcomes (4)
Changes from baseline in patients' overall Impression of Change (PGIC) scale scores after week 1, 2, 3 and 4 of treatment (Day 7, Day 14, Day 21, Day 28)
Measured: Day 7, Day 14, Day 21, Day 28
Changes from baseline in the total score of the Leicester Cough Questionnaire (LCQ), which assessed cough-specific quality of life, at 2 and 4 weeks after treatment (Day 14, Day 28)
Measured: Baseline (Day-1), Day 14, Day 28
Changes from baseline in the simple cough severity score (CET) at week 1, 2, 3, and 4 after treatment (Day 7, Day 14, Day 21, Day 28)
Measured: Day 7, Day 14, Day 21, Day 28
Incidence and severity of any adverse events (AE)
Measured: up to 6 weeks (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start9 Mar 2023
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
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.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733533
- Sponsor's protocol ID
- HRS-2261-201
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2023
- Last updated
- 21 Jan 2026
- Results posted
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study of Efficacy and Safety of HRS-2261 in Refractory Chronic Cough
- ClinicalTrials.gov ID
- NCT05733533
- Acronym / sponsor ID
- HRS-2261-201
- Conditions
- Refractory Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 17 Feb 2023 (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 phase II study that will investigate the efficacy, safety and tolerability of HRS-2261 in subjects with refractory chronic cough using a double blind, placebo controlled, randomized study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-2261 oral tablet | Experimental | Drug: HRS-2261 oral tablet |
| Matching placebo to HRS-2261 | Placebo comparator | Drug: Matching placebo to HRS-2261 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age;
- Diagnosed with refractory chronic cough or chronic cough of unknown cause, with a course of disease lasting more than 1 year;
- Within 5 years prior to screening and after the onset of chronic cough, chest imaging did not reveal any significant abnormalities that the investigators considered to cause chronic cough or any other clinically significant lung disease;
- VAS scores of cough severity in screening period and baseline period ≥ 40 mm;
- Subjects receiving medication for pre-existing underlying conditions prior to the screening period should stabilize the corresponding dose for at least 8 weeks prior to screening;
Key exclusion criteria (17 listed)
- Patients diagnosed with chronic obstructive pulmonary disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis (IPF), and endobronchial tuberculosis;
- Patients with a history of chronic bronchitis;
- Patients with a history of upper or lower respiratory tract infection, or acute exacerbation of respiratory disease, or significant changes in chest imaging within 4 weeks prior to baseline period;
- Current smokers, smokers who have quit smoking (within 6 months), or former smokers who consume more than 20 packs of cigarettes per year;
- Those with abnormal taste within 3 months prior to previous diagnosis or screening;
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 |
|---|---|---|
| HRS-2261 oral tabletHRS-2261 oral tablet, oral, BID | Drug | HRS-2261 oral tablet |
| Matching placebo to HRS-2261Matching placebo to HRS-2261, oral, BID | Drug | Matching placebo to HRS-2261 |
Primary outcome
Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28)
Time frame: Baseline (Day-1)，Day 28
4 secondary outcomes
Changes from baseline in patients' overall Impression of Change (PGIC) scale scores after week 1, 2, 3 and 4 of treatment (Day 7, Day 14, Day 21, Day 28)
Time frame: Day 7, Day 14, Day 21, Day 28
Changes from baseline in the total score of the Leicester Cough Questionnaire (LCQ), which assessed cough-specific quality of life, at 2 and 4 weeks after treatment (Day 14, Day 28)
Time frame: Baseline (Day-1), Day 14, Day 28
Changes from baseline in the simple cough severity score (CET) at week 1, 2, 3, and 4 after treatment (Day 7, Day 14, Day 21, Day 28)
Time frame: Day 7, Day 14, Day 21, Day 28
Incidence and severity of any adverse events (AE)
Time frame: up to 6 weeks (Day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-2261 oral tablet in people with Refractory Chronic Cough, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
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 8 inclusion and 17 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28) (time frame: Baseline (Day-1)，Day 28). 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 21 Jan 2026.