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A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough

Primary Purpose

Refractory Chronic Cough

Status
Enrolling by invitation
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HRS-2261 oral tablet
Matching placebo to HRS-2261
Sponsored by
Guangdong Hengrui Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Chronic Cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥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. Exclusion Criteria: 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; 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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HRS-2261 oral tablet

Matching placebo to HRS-2261

Arm Description

Outcomes

Primary Outcome Measures

Changes from baseline in visual analog Scale (VAS) scores of cough severity after 4 weeks of treatment (Day 28)

Secondary Outcome Measures

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)
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)
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)
Incidence and severity of any adverse events (AE)

Full Information

First Posted
February 8, 2023
Last Updated
June 4, 2023
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05733533
Brief Title
A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough
Official Title
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Study of Efficacy and Safety of HRS-2261 in Refractory Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HRS-2261 oral tablet
Arm Type
Experimental
Arm Title
Matching placebo to HRS-2261
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HRS-2261 oral tablet
Intervention Description
HRS-2261 oral tablet, oral, BID
Intervention Type
Drug
Intervention Name(s)
Matching placebo to HRS-2261
Intervention Description
Matching placebo to HRS-2261, oral, BID
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Incidence and severity of any adverse events (AE)
Time Frame
up to 6 weeks (Day 42)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥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. Exclusion Criteria: 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; 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.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study to Assess the Efficacy and Tolerance of HRS-2261 in Subjects With Refractory Chronic Cough

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