CoughPhase 2NCT06920836
QR052107B Tablets in Patients With Subacute Cough of Phase Ⅱ Study
A Phase 2 study testing QR052107B 100 mg and QR052107B 400 mg in people with Cough, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg， QR052107B 400mg in Patients with Subacute Cough. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough
- What is being tested?
- QR052107B 100 mg and QR052107B 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 25 Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 (both inclusive), male or female.
- Subjects with 18 kg/m2 ≤ BMI ≤ 30 kg/m2 at screening.
- Subjects who have been diagnosed by the investigator with subacute cough (course of disease: 3-8 weeks) following respiratory tract infection.
- Subjects who are willing to discontinue previous antitussives at screening.
- Subjects who are willing to discontinue traditional Chinese medicines or Chinese patent medicines at screening.
- Agreement to use at least one effective method of contraception during the study and for 3 months after the final dose.
- Subjects who agree not to donate any sperm or egg during the study and for 3 months after the final dose.
- Subjects who agree to sign the ICF and comply with all aspects of the study.
Who cannot join
- Subjects with SPO2 ≤ 93% or significant polypnoea at rest during screening.
- Subjects who have undergone chest X-ray or CT within 2 weeks before screening and have clinically significant lung lesions as judged by the investigator.
- Subjects with cough and a large amount of thick phlegm that is difficult to expectorate and facing more safety risks in this study as judged by the investigator.
- Subjects with acute respiratory tract infection (such as sputum purulent, pyrexia, white blood cell count increased or neutrophil count increased, and hs-CRP increased) as judged by the investigator at screening.
- Subjects with infection in systems other than the respiratory system requiring systemic anti-infective therapy as judged by the investigator at screening.
- Subjects with a history of chronic sinusitis, rhinitis allergic, seasonal cough and cough variant asthma (CVA), or with a history of systemic skin/mucosa allergy within 8 weeks before screening.
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- Subjects with a clear history of lung disorders (such as bronchial asthma, chronic obstructive pulmonary disease, pneumonia interstitial, pulmonary carcinoma and bronchiectasis) and unsuitable for this clinical study as judged by the investigator.
- Subjects with severe or poorly controlled pre-existing diseases of various systems other than the respiratory system (such as liver disorders, chronic kidney disease, severe hematological diseases, chronic cardiac failure congestive [New York Heart Association (NYHA) Class III/IV], acute coronary syndrome, nervous system disorders including cerebrovascular and neuromuscular diseases, and metabolic diseases) and unsuitable for this clinical study as judged by the investigator.
- Subjects with clinically significant abnormalities in clinical laboratory tests at screening and unsuitable for this clinical study as judged by the investigator, including but not limited to the following: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), serum total bilirubin (TBIL), and creatinine (Cr) > 200% × upper limit of normal (ULN).
- History of alcohol or drug abuse in the past year.
- Past or current history of major mental disorders.
- Female subjects who are pregnant or lactating.
- Subjects who are current smokers or have quit smoking within 6 months before screening.
- Subjects who have participated in any other clinical trial within 3 months prior to screening, or are still in the safety washout period (< 5 half-lives) of the previous clinical trial on the first dosing day in this study, whichever is longer.
- Presence of other factors that may increase the risk to subjects, affect the study results, or interfere with their participation in the whole study process, including but not limited to abnormal vital signs, physical examinations, ECGs and/or clinical laboratory tests, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of QR052107B Tablets in Patients With Subacute Cough
The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg， QR052107B 400mg in Patients with Subacute Cough.
Read the detailed description
This study adopted a multicenter, randomized, parallel-group, double-blind and placebo-controlled design, and it was planned to enroll 270 patients with subacute cough following respiratory tract infection. After a screening period of 1-4 days, eligible subjects were randomized to the QR052107B 100 mg QD group, QR052107B 400 mg QD group and placebo group at a ratio of 1:1:1. The efficacy of QR052107B Tablets in the treatment of subacute cough was evaluated after 9 consecutive days of dosing. This study is divided into 3 stages: screening period, administration and observation period, and safety follow-up period.
- Conditions
- Cough
- Being tested
- QR052107B 100 mg, QR052107B 400 mg, Placebo
- Keywords
- Subacute Cough, selective P2X3 antagonist
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR052107B 100 mgDrug
QR052107B 100 mg QD
QR052107B 400 mgDrug
QR052107B 400 mg QD
PlaceboDrug
placebo QD
| Study group | Role | What they receive |
|---|---|---|
| QR052107B 100 mg QD | Active comparator | Participants will be treated with one tablet of QR052107B 100mg, three tablets of placebo once daily for up to 9 days. Receives: Drug: QR052107B 100 mg |
| QR052107B 400 mg QD | Active comparator | Participants will be treated with four tablets of QR052107B 100mg once daily for up to 9 days. Receives: Drug: QR052107B 400 mg |
| placebo QD | Placebo comparator | Participants will be treated with four tablets of placebo once daily for up to 9 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMR of mean coughs per hour within 24 hours on D10 versus baseline
The geometric mean ratio (GMR) of mean coughs per hour within 24 hours on day10 versus baseline.
Measured: Baseline and day 10
Secondary outcomes (8)
GMR of mean coughs per hour within 24 h on D10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline.
Measured: Baseline and day 10
GMR of mean coughs per hour within 24 h on D4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day 4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline.
Measured: Baseline and day 4
GMR of mean coughs per hour within 24 hours on D4 versus baseline
The geometric mean ratio of mean coughs per hour within 24 hours on day 4 versus baseline.
Measured: Baseline and day 4
GMR of mean awake coughs per hour on D10 versus baseline
The geometric mean ratio of mean awake coughs per hour on day 10 versus baseline.
Measured: Baseline and day 10
GMR of mean awake coughs per hour on D4 versus baseline
The geometric mean ratio of mean awake coughs per hour on day 4 versus baseline.
Measured: Baseline and day 4
Change from baseline in cough severity VAS score on D4 and D10
The changes in cough severity VAS score on D4 and D10 relative to baseline.
Measured: Baseline, day 4 and day10
Change from baseline in LCQ-acute score on D4 and D10
The changes in LCQ-acute score on D4 and D10 relative to baseline.
Measured: Baseline, day 4 and day10
Change from baseline in sleep VAS score on D4 and D10
The changes in sleep VAS score on D4 and D10 relative to baseline.
Measured: Baseline, day 4 and day10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start21 Jun 2023
- Primary completion22 Nov 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Eligible subjects were randomized at a ratio of 1:1:1 into QR052107B 100 mg QD, QR052107B 400 mg QD and placebo groups and then entered the administration and observation period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ting Yang, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920836
- Sponsor's protocol ID
- QR052107B-YJXKS-2-1
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of QR052107B Tablets in Patients With Subacute Cough
- ClinicalTrials.gov ID
- NCT06920836
- Acronym / sponsor ID
- QR052107B-YJXKS-2-1
- Conditions
- Cough
- Keywords
- Subacute Cough, selective P2X3 antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 10 Apr 2025 (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.
The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg， QR052107B 400mg in Patients with Subacute Cough.
Detailed description
This study adopted a multicenter, randomized, parallel-group, double-blind and placebo-controlled design, and it was planned to enroll 270 patients with subacute cough following respiratory tract infection. After a screening period of 1-4 days, eligible subjects were randomized to the QR052107B 100 mg QD group, QR052107B 400 mg QD group and placebo group at a ratio of 1:1:1. The efficacy of QR052107B Tablets in the treatment of subacute cough was evaluated after 9 consecutive days of dosing. This study is divided into 3 stages: screening period, administration and observation period, and safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Eligible subjects were randomized at a ratio of 1:1:1 into QR052107B 100 mg QD, QR052107B 400 mg QD and placebo groups and then entered the administration and observation period.
| Arm | Type | Receives |
|---|---|---|
| QR052107B 100 mg QD | Active comparator | Drug: QR052107B 100 mgParticipants will be treated with one tablet of QR052107B 100mg, three tablets of placebo once daily for up to 9 days. |
| QR052107B 400 mg QD | Active comparator | Drug: QR052107B 400 mgParticipants will be treated with four tablets of QR052107B 100mg once daily for up to 9 days. |
| placebo QD | Placebo comparator | Drug: PlaceboParticipants will be treated with four tablets of placebo once daily for up to 9 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-75 (both inclusive), male or female.
- Subjects with 18 kg/m2 ≤ BMI ≤ 30 kg/m2 at screening.
- Subjects who have been diagnosed by the investigator with subacute cough (course of disease: 3-8 weeks) following respiratory tract infection.
- Subjects who are willing to discontinue previous antitussives at screening.
- Subjects who are willing to discontinue traditional Chinese medicines or Chinese patent medicines at screening.
Key exclusion criteria (15 listed)
- Subjects with SPO2 ≤ 93% or significant polypnoea at rest during screening.
- Subjects who have undergone chest X-ray or CT within 2 weeks before screening and have clinically significant lung lesions as judged by the investigator.
- Subjects with cough and a large amount of thick phlegm that is difficult to expectorate and facing more safety risks in this study as judged by the investigator.
- Subjects with acute respiratory tract infection (such as sputum purulent, pyrexia, white blood cell count increased or neutrophil count increased, and hs-CRP increased) as judged by the investigator at screening.
- Subjects with infection in systems other than the respiratory system requiring systemic anti-infective therapy as judged by the investigator at 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 |
|---|---|---|
| QR052107B 100 mgQR052107B 100 mg QD | Drug | QR052107B 100 mg QD |
| QR052107B 400 mgQR052107B 400 mg QD | Drug | QR052107B 400 mg QD |
| Placeboplacebo QD | Drug | placebo QD |
Primary outcome
GMR of mean coughs per hour within 24 hours on D10 versus baseline
Time frame: Baseline and day 10
The geometric mean ratio (GMR) of mean coughs per hour within 24 hours on day10 versus baseline.
8 secondary outcomes
GMR of mean coughs per hour within 24 h on D10 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
Time frame: Baseline and day 10
GMR of mean coughs per hour within 24 h on D4 versus baseline in patients of ≥ 20 coughs per hour within 24 h at baseline
Time frame: Baseline and day 4
GMR of mean coughs per hour within 24 hours on D4 versus baseline
Time frame: Baseline and day 4
GMR of mean awake coughs per hour on D10 versus baseline
Time frame: Baseline and day 10
GMR of mean awake coughs per hour on D4 versus baseline
Time frame: Baseline and day 4
Change from baseline in cough severity VAS score on D4 and D10
Time frame: Baseline, day 4 and day10
Change from baseline in LCQ-acute score on D4 and D10
Time frame: Baseline, day 4 and day10
Change from baseline in sleep VAS score on D4 and D10
Time frame: Baseline, day 4 and day10
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ting Yang, MD principal investigator
China-Japan Friendship Hospital
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 QR052107B 100 mg and QR052107B 400 mg in people with Cough, run by Wuhan Createrna Science and Technology 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 15 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 10 Apr 2025. 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?
GMR of mean coughs per hour within 24 hours on D10 versus baseline (time frame: Baseline and day 10). 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 10 Apr 2025.