QR052107B Tablets in Patients With Subacute Cough of Phase Ⅱ Study

April 7, 2025 updated by: Wuhan Createrna Science and Technology Co., Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • China-Japan Friendship Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-75 (both inclusive), male or female.
  2. Subjects with 18 kg/m2 ≤ BMI ≤ 30 kg/m2 at screening.
  3. Subjects who have been diagnosed by the investigator with subacute cough (course of disease: 3-8 weeks) following respiratory tract infection.
  4. Subjects who are willing to discontinue previous antitussives at screening.
  5. Subjects who are willing to discontinue traditional Chinese medicines or Chinese patent medicines at screening.
  6. Agreement to use at least one effective method of contraception during the study and for 3 months after the final dose.
  7. Subjects who agree not to donate any sperm or egg during the study and for 3 months after the final dose.
  8. Subjects who agree to sign the ICF and comply with all aspects of the study.

Exclusion Criteria:

  1. Subjects with SPO2 ≤ 93% or significant polypnoea at rest during screening.
  2. 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.
  3. 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.
  4. 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.
  5. Subjects with infection in systems other than the respiratory system requiring systemic anti-infective therapy as judged by the investigator at screening.
  6. 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.
  7. 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.
  8. 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.
  9. 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).
  10. History of alcohol or drug abuse in the past year.
  11. Past or current history of major mental disorders.
  12. Female subjects who are pregnant or lactating.
  13. Subjects who are current smokers or have quit smoking within 6 months before screening.
  14. 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.
  15. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: QR052107B 100 mg QD
Participants will be treated with one tablet of QR052107B 100mg, three tablets of placebo once daily for up to 9 days.
Drug: QR052107B 100 mg
QR052107B 100 mg QD
Active Comparator: QR052107B 400 mg QD
Participants will be treated with four tablets of QR052107B 100mg once daily for up to 9 days.
Drug: QR052107B 400 mg
QR052107B 400 mg QD
Placebo Comparator: placebo QD
Participants will be treated with four tablets of placebo once daily for up to 9 days.
Drug: Placebo
placebo QD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
Baseline and day 4
GMR of mean coughs per hour within 24 hours on D4 versus baseline
Time Frame: Baseline and day 4
The geometric mean ratio of mean coughs per hour within 24 hours on day 4 versus baseline.
Baseline and day 4
GMR of mean awake coughs per hour on D10 versus baseline
Time Frame: Baseline and day 10
The geometric mean ratio of mean awake coughs per hour on day 10 versus baseline.
Baseline and day 10
GMR of mean awake coughs per hour on D4 versus baseline
Time Frame: Baseline and day 4
The geometric mean ratio of mean awake coughs per hour on day 4 versus baseline.
Baseline and day 4
Change from baseline in cough severity VAS score on D4 and D10
Time Frame: Baseline, day 4 and day10
The changes in cough severity VAS score on D4 and D10 relative to baseline.
Baseline, day 4 and day10
Change from baseline in LCQ-acute score on D4 and D10
Time Frame: Baseline, day 4 and day10
The changes in LCQ-acute score on D4 and D10 relative to baseline.
Baseline, day 4 and day10
Change from baseline in sleep VAS score on D4 and D10
Time Frame: Baseline, day 4 and day10
The changes in sleep VAS score on D4 and D10 relative to baseline.
Baseline, day 4 and day10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuhan Createrna Science and Technology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ting Yang, MD, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QR052107B-YJXKS-2-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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