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A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HRG2005 inhalation
Placebo to match HRG2005 inhalation
Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

Inclusion Criteria: Able and willing to provide written informed consent and to comply with the study protocol; Subjects 40 years of age or older (inclusive), Male or female subjects; Subjects with an established clinical history of COPD; A post-bronchodilator FEV1/FVC ratio must be <0.7 at Screening and FEV1 must be <80% and ≥30% predicted normal at pre-randomization; Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking.; A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization. Exclusion Criteria: Subjects who required systemic corticosteroids or antibiotics or hospitalized due to poorly controlled COPD or who had lower respiratory tract infections that required antibiotics within 4 weeks prior to Screening to pre-randomization; Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening; Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary disease; Subjects with lung volume reduction surgery within the 12 months prior to Screening; Subjects who have Other known serious medical conditions; Subjects receiving oxygen therapy required for greater than 15 hours a day; Clinically significant electrocardiogram abnormality; Subjects with significant laboratory abnormality at screening; Suspected allergy to any ingredient in the study drug; Participation in clinical trials of any drug or medical device (except for screening failures) within 4 weeks before screening, or within 5 half-lives of the drug at screening (whichever is longer); Pregnant or lactating females; History of drug abuse, drinking within one year before screening Other conditions judged by the investigator to be not suitable to participate in the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Other

    Arm Label

    Treatment group A

    Treatment group B

    Treatment group C

    Treatment group D

    Arm Description

    Drug1 dose 1+Drug 3

    Drug1 dose 2+Drug 2+Drug 3

    Drug1 dose 3+Drug 2+Drug 3

    Drug 2+Drug 4

    Outcomes

    Primary Outcome Measures

    Change from baseline in morning pre-dose trough FEV1 at week 12

    Secondary Outcome Measures

    Change from baseline in morning pre-dose trough FEV1 at each time point
    Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
    Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
    Peak change from baseline in FEV1 at week 12
    FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12
    Rate of moderate or severe COPD exacerbations over 48 Weeks
    Rate of severe COPD exacerbations over 48 Weeks
    Change from baseline in CAT (COPD Assessment test) total score at each time point
    Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
    Incidence and severity of adverse events

    Full Information

    First Posted
    September 7, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06035393
    Brief Title
    A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
    Official Title
    A Phase II, Randomized, Double Blind, Double Dummy, Active-controlled, Parallel-group Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 27, 2023 (Anticipated)
    Primary Completion Date
    August 28, 2025 (Anticipated)
    Study Completion Date
    August 28, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine 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 randomized, double blind, double dummy, active-controlled, parallel-group study to assess the efficacy and Safety of HRG2005 inhalation in patients with moderate to severe chronic obstructive pulmonary disease. Approximately 200 patients with moderate to severe COPD will be randomized into the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized, double blind, double dummy, active-controlled, parallel-group study.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group A
    Arm Type
    Experimental
    Arm Description
    Drug1 dose 1+Drug 3
    Arm Title
    Treatment group B
    Arm Type
    Experimental
    Arm Description
    Drug1 dose 2+Drug 2+Drug 3
    Arm Title
    Treatment group C
    Arm Type
    Experimental
    Arm Description
    Drug1 dose 3+Drug 2+Drug 3
    Arm Title
    Treatment group D
    Arm Type
    Other
    Arm Description
    Drug 2+Drug 4
    Intervention Type
    Drug
    Intervention Name(s)
    HRG2005 inhalation
    Intervention Description
    Drug 1: dose 1; dose 2; dose 3
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to match HRG2005 inhalation
    Intervention Description
    Drug 2
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to match Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
    Intervention Description
    Drug 3
    Intervention Type
    Drug
    Intervention Name(s)
    Indacaterol Maleate and Glycopyrronium Bromide Powder for inhalation
    Intervention Description
    Drug 4
    Primary Outcome Measure Information:
    Title
    Change from baseline in morning pre-dose trough FEV1 at week 12
    Time Frame
    Up to week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in morning pre-dose trough FEV1 at each time point
    Time Frame
    up to week 48
    Title
    Compared with the active-controlled group in morning pre-dose trough FEV1 at each time point
    Time Frame
    up to week 48
    Title
    Proportion of subjects achieving an improvement from baseline≥100mL in morning pre-dose trough FEV1
    Time Frame
    up to week 48
    Title
    Peak change from baseline in FEV1 at week 12
    Time Frame
    Up to week 12
    Title
    FEV1 area under the curve from 0 to 12 hours (AUC0-12), 0 to 24 (AUC0-24) hours at Week 12
    Time Frame
    Up to week 12
    Title
    Rate of moderate or severe COPD exacerbations over 48 Weeks
    Time Frame
    up to week 48
    Title
    Rate of severe COPD exacerbations over 48 Weeks
    Time Frame
    up to week 48
    Title
    Change from baseline in CAT (COPD Assessment test) total score at each time point
    Time Frame
    up to week 48
    Title
    Percentage of Days with No Rescue use and change from baseline in average daily rescue use at each time point
    Time Frame
    up to week 48
    Title
    Incidence and severity of adverse events
    Time Frame
    Up to week 50

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able and willing to provide written informed consent and to comply with the study protocol; Subjects 40 years of age or older (inclusive), Male or female subjects; Subjects with an established clinical history of COPD; A post-bronchodilator FEV1/FVC ratio must be <0.7 at Screening and FEV1 must be <80% and ≥30% predicted normal at pre-randomization; Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking.; A score of ≥10 on the COPD Assessment Test (CAT) at pre-randomization. Exclusion Criteria: Subjects who required systemic corticosteroids or antibiotics or hospitalized due to poorly controlled COPD or who had lower respiratory tract infections that required antibiotics within 4 weeks prior to Screening to pre-randomization; Subjects who had respiratory tract infections that required antibiotics within 2 weeks prior to Screening; Subjects with other respiratory or respiratory related diseases, including but not limited to asthma, active tuberculosis, lung cancer, interstitial pulmonary disease, α1-antitrypsin deficiency, pulmonary heart disease, clinically significant pulmonary hypertension, clinically significant bronchiectasis, or other active pulmonary disease; Subjects with lung volume reduction surgery within the 12 months prior to Screening; Subjects who have Other known serious medical conditions; Subjects receiving oxygen therapy required for greater than 15 hours a day; Clinically significant electrocardiogram abnormality; Subjects with significant laboratory abnormality at screening; Suspected allergy to any ingredient in the study drug; Participation in clinical trials of any drug or medical device (except for screening failures) within 4 weeks before screening, or within 5 half-lives of the drug at screening (whichever is longer); Pregnant or lactating females; History of drug abuse, drinking within one year before screening Other conditions judged by the investigator to be not suitable to participate in the trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaopeng Wang
    Phone
    0518-81220121
    Email
    xiaopeng.wang@hengrui.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yin Tong
    Phone
    0518-81220121
    Email
    yin.tong@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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