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A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQC3721 suspension for inhalation
TQC3721 matching placebo for inhalation
Salbutamol sulfate inhalation aerosol
Sponsored by
Chia Tai Tianqing Pharmaceutical Group 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

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sign an informed consent form before the study and fully understand the content, process, and potential adverse reactions of the experiment; Capable of using the study nebulizer correctly and complying with all study restrictions and procedures; Aged between 30 and 75 years old (Including critical values), both men and women; Body mass index(BMI) within the range of 18-30 kg/m2 (Including critical values); The subject has no pregnancy plan and voluntarily adopts effective contraceptive measures for at least one month from screening until the last use of the study drug; Diagnosed as a COPD patient according to the Global initiative for chronic obstructive lung disease (GOLD) 2023 standard, and had symptoms that met COPD for at least 1 year before screening; Able to conduct acceptable and repeatable lung function measurements; Clinical stability of COPD within 4 weeks before screening visit (V1) and between V1 visit and V2 visit; Long acting Bronchiectasis or short acting Bronchiectasis were not regularly used at least 14 days before screening visit (V1); Long acting Bronchiectasis can be stopped during the study until the end of the study, and short acting Bronchiectasis can be stopped at least 6 hours before the pulmonary function test; Meet the restrictions on combination medication and expect to maintain the restrictions during treatment; Current smoking or smoking history ≥ 10 pack years (smoking at least 20 cigarettes per day for 10 consecutive years or smoking at least 10 cigarettes per day for 20 consecutive years, former cigarette smokers must stop smoking>6 months before visit 1). Exclusion Criteria: A history of life-threatening COPD, including hospitalization in an intensive care unit and/or the need for intubation. Acute exacerbations of COPD requiring oral or parenteral steroid treatment within 3 months before screening (V1) or before randomization (V2). Received inhaled corticosteroids (ICS) treatment within 4 weeks prior to screening. Have a history of hospitalization for COPD at least once within 6 months prior to screening. Antibiotic treatment for upper and/or lower respiratory tract infection within 6 weeks before screening or before randomized visit (V2). Note: Patients with a history of upper/lower respiratory tract infection within 6 weeks cannot participate in the test, but can be re-screened 6 weeks after the infection is cured. COVID-19: Suspected or confirmed COVID-19 infection during screening (V1), confirmed by the laboratory or based on the medical judgment of the researcher; Subjects who are known to have contact with COVID-19 positive patients. Note: Subjects should remain Asymptomatic for 14 days or more after exposure, and only after being approved by the investigator can they be re-screened. Known COVID-19 infection history within 4 weeks before screening (V1); Known medical history of hospitalization due to COVID-19 within 3 months before screening (V1); Subjects who had COVID-19 infection before screening (V1) and had not fully recovered to participate in clinical trial operations. Suffering from other respiratory diseases simultaneously: α- 1. Antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; Respiratory diseases such as active pulmonary infection, pulmonary tuberculosis, Bronchiectasis, Pulmonary fibrosis, pulmonary Sarcoidosis, pulmonary hypertension, etc. with significant clinical significance assessed by the researchers. Chest computed tomography (CT) has found clinically significant abnormalities and believes that the abnormalities are not caused by COPD, and the researchers have determined that they have an impact on the trial results or patient safety. If there is no chest CT report within 3 months before visit 1, a chest CT examination must be performed on visit 1. Previously underwent pneumonectomy or lung reduction surgery. Previously received lung rehabilitation treatment (those who have been stable for 4 weeks before screening and have remained stable during the trial period can be selected). Received oral steroids or roflumilast treatment for COPD within 3 months before screening (Visit 1), or received oral theophylline and/or theophylline derivatives treatment for COPD within 1 months before screening (V1). Use non-selective oral administration β Receptor blockers. Previously received treatment with ensifentrine and HRS-9821. Patients receiving immunotherapy (such as Azathioprine and Cyclophosphamide) within 4 weeks before the screening period. The researcher evaluated that during the screening and treatment stages of this study, patients were unable to discontinue the prohibited drugs specified in the protocol. The patient has a history of diseases that cannot be controlled at present, including but not limited to diseases of endocrine, thyroid, nervous system, liver, gastrointestinal tract, kidney, blood, Urinary system, immunology or ophthalmic diseases which the investigator judges are clinically significant. History or current evidence of cardiovascular diseases with clinical significance. It is defined as any disease that the investigator believes will endanger the safety of patients when participating in the study, or any disease that may affect the effectiveness or safety analysis if the disease/condition worsens during the study; Subjects who have experienced any of the following conditions during visit 1 will be excluded: myocardial infarction, unstable angina, or stroke within the past 6 months; There have been unstable or life-threatening arrhythmia requiring intervention within the past 3 months; New York Heart Association (NYHA) III-IV Heart Failure. Have unstable or uncontrollable hypertension. Major surgery (requiring general anesthesia) was performed within 8 weeks before the screening visit (V1), or the patient did not fully recover from the surgery during the screening visit (V1), or surgery was planned before the end of the study. A history of cured or uncured malignant tumors in any organ or system in the past 5 years. Intolerance or allergy to Salbutamol or TQC3721. Those who require oxygen therapy, even occasionally. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study. Persons who have received live attenuated vaccine within 28 days before randomization, Inactivated vaccine within 7 days, or who plan to receive vaccination during the study period. Have a history of drug or alcohol abuse within the past 3 years. Individuals who have participated in any clinical trial of drugs or medical devices within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening. The researcher believes that there are other situations that are not suitable for participation in the study.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The Affiliated Hospital of Guangdong Medical UniversityRecruiting
  • Wuhan Sixth HospitalRecruiting
  • Changsha Third HospitalRecruiting
  • Northern Jiangsu People's HospitalRecruiting
  • People's Hospital of Jiangxi provinceRecruiting
  • The first hospital of Jilin UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Mianyang Central HospitalRecruiting
  • Suining Central HospitalRecruiting
  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol

TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol

TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol

TQC3721 matching placebo for inhalation (once a day)+ Salbutamol

Arm Description

TQC3721 suspension for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.

TQC3721 suspension for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.

TQC3721 suspension placebo for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.

TQC3721 suspension placebo for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.

Outcomes

Primary Outcome Measures

The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Change of the maximum value of FEV1 from baseline to four weeks after treatment

Secondary Outcome Measures

Morning trough FEV1
The FEV1 before administration
Average FEV1 (4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Changes in FEV1
Changes in FEV1 at each time point within 24 hours after administration
COPD Assessment Test (CAT)
Change From Baseline to four weeks after treatment. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe).
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Change From Baseline to four weeks after treatment in mMRC Scoring. The questionnaire is mainly used to evaluate the degree of respiratory distress in patients with chronic obstructive pulmonary disease. According to the symptoms of respiratory distress, the questionnaire is divided into 5 levels, with 0-1 points as less symptoms and ≥ 2 points as more symptoms.
The peak of FEV1 (two weeks)
Change of the maximum value of FEV1 from baseline to two weeks after treatment
Trough FEV1
Change of trough FEV1 from baseline to two weeks after treatment.
Average FEV1 within 3 hours
Average FEV1 within 3 hours after administration
Frequency of Rescue medication
Frequency of Rescue medication used group during the study in the experimental compared to that in the placebo group.
Plasma drug peak concentration (Cmax)
Plasma drug peak concentration after administration.
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) after administration.
Area Under Curve (AUC)
Area under the drug concentration-time curve.
Elimination half-life (t1/2)
Apparent terminal elimination half-life after drug administration.
Apparent volume of distribution (Vd)
Apparent volume of distribution after drug administration.
Clearance (CL)
The total drug clearance rate of liver, kidney, etc.
Plasma concentration at steady state (Cav, SS)
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Minimum concentration (Cmin)
Plasma drug minimum concentration after administration.
Degree of fluctuation (DF)
The ratio of the difference between Cmax,ss and Cmin,ss to Cav,ss.
Steady state volume of distribution (Vss)
Steady state volume of distribution after administration.
Number of cases of adverse events
Number of cases of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Incidence of adverse events
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Number of cases of serious adverse events.
Number of cases of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Incidence of serious adverse events.
Incidence of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Number of cases of adverse events related to study drug.
Number of cases of adverse events related to study drug assessed by CTCAE v5.0.
Incidence of adverse events related to study drug.
Incidence of adverse events related to study drug assessed by CTCAE v5.0.
The peak of FEV1 (Day 1).
Change of the maximum value of FEV1 from baseline to Day 1.
The peak of FEV1 (Day 1 to 4 weeks)
Change of the maximum value of FEV1 from Day 1 to four weeks after treatment
Average FEV1 (Day 2)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Average FEV1 (Day 1 to 4 weeks)
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.

Full Information

First Posted
August 4, 2023
Last Updated
September 15, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05987371
Brief Title
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Official Title
Randomized, Double-blind, Placebo-controlled, Dose Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group 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 clinical trial to evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).

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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQC3721 Suspension for Inhalation (Twice a day)+ Salbutamol
Arm Type
Experimental
Arm Description
TQC3721 suspension for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
Arm Title
TQC3721 Suspension for Inhalation (Once a day)+ Salbutamol
Arm Type
Experimental
Arm Description
TQC3721 suspension for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
Arm Title
TQC3721 matching placebo for inhalation (Twice a day)+ Salbutamol
Arm Type
Placebo Comparator
Arm Description
TQC3721 suspension placebo for inhalation, twice a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
Arm Title
TQC3721 matching placebo for inhalation (once a day)+ Salbutamol
Arm Type
Placebo Comparator
Arm Description
TQC3721 suspension placebo for inhalation, once a day for 4 weeks, Salbutamol sulfate inhalation aerosol is used as required.
Intervention Type
Drug
Intervention Name(s)
TQC3721 suspension for inhalation
Intervention Description
TQC3721 suspension for inhalation is a dual inhibitor targeting PDE3/4.
Intervention Type
Drug
Intervention Name(s)
TQC3721 matching placebo for inhalation
Intervention Description
Placebo without active substance.
Intervention Type
Drug
Intervention Name(s)
Salbutamol sulfate inhalation aerosol
Intervention Description
Salbutamol is short-acting β2 receptor agonists.
Primary Outcome Measure Information:
Title
The peak of Forced Expiratory Volume in the 1st second (FEV1) (4 weeks)
Description
Change of the maximum value of FEV1 from baseline to four weeks after treatment
Time Frame
From baseline to four weeks after treatment.
Secondary Outcome Measure Information:
Title
Morning trough FEV1
Description
The FEV1 before administration
Time Frame
From baseline to four weeks after treatment.
Title
Average FEV1 (4 weeks)
Description
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time Frame
From baseline to four weeks after treatment.
Title
Changes in FEV1
Description
Changes in FEV1 at each time point within 24 hours after administration
Time Frame
From baseline to four weeks after treatment.
Title
COPD Assessment Test (CAT)
Description
Change From Baseline to four weeks after treatment. The score range is 0 to 40 points (0 to 10 is minor influence; 11 to 20 are moderate; 21 to 30 are classified as severe impact; 31 to 40 is very severe).
Time Frame
From baseline to four weeks after treatment.
Title
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Description
Change From Baseline to four weeks after treatment in mMRC Scoring. The questionnaire is mainly used to evaluate the degree of respiratory distress in patients with chronic obstructive pulmonary disease. According to the symptoms of respiratory distress, the questionnaire is divided into 5 levels, with 0-1 points as less symptoms and ≥ 2 points as more symptoms.
Time Frame
From baseline to four weeks after treatment.
Title
The peak of FEV1 (two weeks)
Description
Change of the maximum value of FEV1 from baseline to two weeks after treatment
Time Frame
From baseline to two weeks after treatment.
Title
Trough FEV1
Description
Change of trough FEV1 from baseline to two weeks after treatment.
Time Frame
From baseline to two weeks after treatment.
Title
Average FEV1 within 3 hours
Description
Average FEV1 within 3 hours after administration
Time Frame
From baseline to two weeks after treatment
Title
Frequency of Rescue medication
Description
Frequency of Rescue medication used group during the study in the experimental compared to that in the placebo group.
Time Frame
From baseline to four weeks after administration.
Title
Plasma drug peak concentration (Cmax)
Description
Plasma drug peak concentration after administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Time to maximum concentration (Tmax)
Description
Time to maximum concentration (Tmax) after administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Area Under Curve (AUC)
Description
Area under the drug concentration-time curve.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Elimination half-life (t1/2)
Description
Apparent terminal elimination half-life after drug administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Apparent volume of distribution (Vd)
Description
Apparent volume of distribution after drug administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Clearance (CL)
Description
The total drug clearance rate of liver, kidney, etc.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Plasma concentration at steady state (Cav, SS)
Description
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Minimum concentration (Cmin)
Description
Plasma drug minimum concentration after administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Degree of fluctuation (DF)
Description
The ratio of the difference between Cmax,ss and Cmin,ss to Cav,ss.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Steady state volume of distribution (Vss)
Description
Steady state volume of distribution after administration.
Time Frame
Within 60 minutes before administration on Day 1, to 24 hours after administration on Day 28.
Title
Number of cases of adverse events
Description
Number of cases of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
Incidence of adverse events
Description
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
Number of cases of serious adverse events.
Description
Number of cases of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
Incidence of serious adverse events.
Description
Incidence of serious adverse events assessed by Common Terminology Criteria for Adverse Events ( CTCAE ) v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
Number of cases of adverse events related to study drug.
Description
Number of cases of adverse events related to study drug assessed by CTCAE v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
Incidence of adverse events related to study drug.
Description
Incidence of adverse events related to study drug assessed by CTCAE v5.0.
Time Frame
From baseline to four weeks after treatment.
Title
The peak of FEV1 (Day 1).
Description
Change of the maximum value of FEV1 from baseline to Day 1.
Time Frame
From baseline to Day 1.
Title
The peak of FEV1 (Day 1 to 4 weeks)
Description
Change of the maximum value of FEV1 from Day 1 to four weeks after treatment
Time Frame
From Day 1 to four weeks after treatment.
Title
Average FEV1 (Day 2)
Description
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time Frame
From baseline to 24 hours after first treatment.
Title
Average FEV1 (Day 1 to 4 weeks)
Description
Average FEV1 of 3 hours, 12 hours, 24 hours, 0-12 hours and 12-24 hours after administration.
Time Frame
From Day 1 to four weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign an informed consent form before the study and fully understand the content, process, and potential adverse reactions of the experiment; Capable of using the study nebulizer correctly and complying with all study restrictions and procedures; Aged between 30 and 75 years old (Including critical values), both men and women; Body mass index(BMI) within the range of 18-30 kg/m2 (Including critical values); The subject has no pregnancy plan and voluntarily adopts effective contraceptive measures for at least one month from screening until the last use of the study drug; Diagnosed as a COPD patient according to the Global initiative for chronic obstructive lung disease (GOLD) 2023 standard, and had symptoms that met COPD for at least 1 year before screening; Able to conduct acceptable and repeatable lung function measurements; Clinical stability of COPD within 4 weeks before screening visit (V1) and between V1 visit and V2 visit; Long acting Bronchiectasis or short acting Bronchiectasis were not regularly used at least 14 days before screening visit (V1); Long acting Bronchiectasis can be stopped during the study until the end of the study, and short acting Bronchiectasis can be stopped at least 6 hours before the pulmonary function test; Meet the restrictions on combination medication and expect to maintain the restrictions during treatment; Current smoking or smoking history ≥ 10 pack years (smoking at least 20 cigarettes per day for 10 consecutive years or smoking at least 10 cigarettes per day for 20 consecutive years, former cigarette smokers must stop smoking>6 months before visit 1). Exclusion Criteria: A history of life-threatening COPD, including hospitalization in an intensive care unit and/or the need for intubation. Acute exacerbations of COPD requiring oral or parenteral steroid treatment within 3 months before screening (V1) or before randomization (V2). Received inhaled corticosteroids (ICS) treatment within 4 weeks prior to screening. Have a history of hospitalization for COPD at least once within 6 months prior to screening. Antibiotic treatment for upper and/or lower respiratory tract infection within 6 weeks before screening or before randomized visit (V2). Note: Patients with a history of upper/lower respiratory tract infection within 6 weeks cannot participate in the test, but can be re-screened 6 weeks after the infection is cured. COVID-19: Suspected or confirmed COVID-19 infection during screening (V1), confirmed by the laboratory or based on the medical judgment of the researcher; Subjects who are known to have contact with COVID-19 positive patients. Note: Subjects should remain Asymptomatic for 14 days or more after exposure, and only after being approved by the investigator can they be re-screened. Known COVID-19 infection history within 4 weeks before screening (V1); Known medical history of hospitalization due to COVID-19 within 3 months before screening (V1); Subjects who had COVID-19 infection before screening (V1) and had not fully recovered to participate in clinical trial operations. Suffering from other respiratory diseases simultaneously: α- 1. Antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; Respiratory diseases such as active pulmonary infection, pulmonary tuberculosis, Bronchiectasis, Pulmonary fibrosis, pulmonary Sarcoidosis, pulmonary hypertension, etc. with significant clinical significance assessed by the researchers. Chest computed tomography (CT) has found clinically significant abnormalities and believes that the abnormalities are not caused by COPD, and the researchers have determined that they have an impact on the trial results or patient safety. If there is no chest CT report within 3 months before visit 1, a chest CT examination must be performed on visit 1. Previously underwent pneumonectomy or lung reduction surgery. Previously received lung rehabilitation treatment (those who have been stable for 4 weeks before screening and have remained stable during the trial period can be selected). Received oral steroids or roflumilast treatment for COPD within 3 months before screening (Visit 1), or received oral theophylline and/or theophylline derivatives treatment for COPD within 1 months before screening (V1). Use non-selective oral administration β Receptor blockers. Previously received treatment with ensifentrine and HRS-9821. Patients receiving immunotherapy (such as Azathioprine and Cyclophosphamide) within 4 weeks before the screening period. The researcher evaluated that during the screening and treatment stages of this study, patients were unable to discontinue the prohibited drugs specified in the protocol. The patient has a history of diseases that cannot be controlled at present, including but not limited to diseases of endocrine, thyroid, nervous system, liver, gastrointestinal tract, kidney, blood, Urinary system, immunology or ophthalmic diseases which the investigator judges are clinically significant. History or current evidence of cardiovascular diseases with clinical significance. It is defined as any disease that the investigator believes will endanger the safety of patients when participating in the study, or any disease that may affect the effectiveness or safety analysis if the disease/condition worsens during the study; Subjects who have experienced any of the following conditions during visit 1 will be excluded: myocardial infarction, unstable angina, or stroke within the past 6 months; There have been unstable or life-threatening arrhythmia requiring intervention within the past 3 months; New York Heart Association (NYHA) III-IV Heart Failure. Have unstable or uncontrollable hypertension. Major surgery (requiring general anesthesia) was performed within 8 weeks before the screening visit (V1), or the patient did not fully recover from the surgery during the screening visit (V1), or surgery was planned before the end of the study. A history of cured or uncured malignant tumors in any organ or system in the past 5 years. Intolerance or allergy to Salbutamol or TQC3721. Those who require oxygen therapy, even occasionally. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study. Persons who have received live attenuated vaccine within 28 days before randomization, Inactivated vaccine within 7 days, or who plan to receive vaccination during the study period. Have a history of drug or alcohol abuse within the past 3 years. Individuals who have participated in any clinical trial of drugs or medical devices within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening. The researcher believes that there are other situations that are not suitable for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weimin Li, Doctor
Phone
+86 028-85423998
Email
weimin003@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luqian Zhou, Doctor
Phone
+86 18926132976
Email
41858702@qq.com
Facility Name
The Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524023
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Wu, Doctor
Phone
+86 13590090068
Email
Wubin621011@126.com
Facility Name
Wuhan Sixth Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fajiu Li, Bachelor
Phone
+86 18627933943
Email
80670519@qq.com
Facility Name
Changsha Third Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingqun Zhu, Master
Phone
+86 13319559218
Email
1104633835@qq.com
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingxiang Xu, Doctorc
Phone
+86 18051062315
Email
Xuxx63@sina.com
Facility Name
People's Hospital of Jiangxi province
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuke Xiao, Bachelor
Phone
+86 15979159878
Email
Xiaozuke@126.com
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Peng, Doctor
Phone
+86 13756661263
Email
plp640317@163.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Li, Doctor
Phone
+86 028-85423998
Email
weimin003@163.com
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li, Doctor
Phone
+86 13778019980
Email
417381345@qq.com
Facility Name
Suining Central Hospital
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobin Luo, Master
Phone
+86 18008258560
Email
415322095@qq.com
Facility Name
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325088
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqin Wu, Master
Phone
+86 13587861043
Email
happy-qin@163.com

12. IPD Sharing Statement

Learn more about this trial

A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.

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