A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

June 1, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Double-blind, Placebo-parallel, Multicenter Phase II Trial of the Efficacy and Safety of TQC3721 Suspension for Inhalation in the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease

TQC3721 suspension for inhalation is a PDE3/4 inhibitor developed by Chia Tai Tianqing Pharmaceutical Group Co., LTD., which can simultaneously achieve bronchial smooth muscle relaxation and anti-inflammatory effects. This is a randomized, double-blind, placebo-parallel, phase II trial of the efficacy and safety of inhaled TQC3721 suspension/placebo at different doses in patients with moderate to severe chronic obstructive pulmonary disease. Objective To evaluate the efficacy, safety and tolerability of TQC3721 inhalation suspension in the treatment of moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

460

Phase

  • 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 Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730700
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
    • Guangdong
      • Zhanjiang, Guangdong, China, 524023
        • Recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150001
        • Recruiting
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
      • Yangzhou, Jiangsu, China, 225000
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:
    • Jianxi
      • Nanchang, Jianxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Mianyang, Sichuan, China, 621099
        • Recruiting
        • Mianyang Central Hospital
        • Contact:

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test;
  • 2 Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
  • 3 Aged between 18 and 75 years old, both men and women;
  • 4 Body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value) and body weight is ≥45kg;
  • 5 Subjects have no pregnancy plan and have voluntarily taken effective contraceptive measures for at least 1 month after being screened to the last use of the study drug;
  • 6 12-lead electrocardiogram with QT interval corrected ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no morphologic and other clinical significant abnormalities that the investigator considered inappropriate for the study;
  • 7 Ability to perform acceptable and reproducible spirometry;
  • 8 Patients previously treated with LAMA or LABA who had evidence of stable use for at least 3 months prior to screening and agreed to continue use during the study period;
  • 9 Capable of withholding LAMA or LABA（ Twice-Daily maintenance LAMA or LABA for at least 24 hours and Once-Daily maintenance LAMA or LABA for at least 48 hours) and SAMA、SABAs（at least 4 hours）prior to initiation of any spirometry;
  • 10 According to the 2020 GOLD Guidelines, Post-bronchodilator spirometry at screening must demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥30 % to ≤80% of predicted normal;
  • 11 Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, former cigarette smokers should stop smoke at least 6 months before visit 1).

Exclusion Criteria:

  • 1 Intolerance to salbutamol or this product.
  • 2 ≥1 hospitalization for COPD treatment within 6 months prior to screening.
  • 3 Antibiotic treatment for lower respiratory tract infection within 3 months prior to screening.
  • 4 Use of prohibited medications within the time intervals.
  • 5 Patients who were currently diagnosed with asthma, active tuberculosis, lung cancer and other active lung diseases and were considered unsuitable for the study.
  • 6 Previous lung resection or lung reduction surgery.
  • 7 Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
  • 8 A history of drug or alcohol abuse in the past 3 years (14 units of alcohol consumed per week: 1 unit =360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine).
  • 9 Have participated in a clinical trial within one month prior to screening or within 5 half-lives of the investigational drug, whichever is the longer.
  • 10 Women who are breast-feeding.
  • 11 A history of myocardial infarction, congestive heart failure, and unstable or uncontrolled hypertension (systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100mmHg after drug control) within 6 months prior to screening.
  • 12 History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin.
  • 13 Alanine aminotransferase (ALT) or aspartate aminotransferase(AST)≥ 2 x upper limit of normal (ULN), or other abnormal test results were deemed unsuitable for inclusion by the investigator.
  • 14 Required use of oxygen therapy, even on an occasional basis.
  • 15 Other conditions that the investigator considered inappropriate for participation in the study.

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
Intervention / Treatment
Experimental: TQC3721 suspension for inhalation
TQC3721 suspension for inhalation, four weeks as a treatment cycle.
Drug: TQC3721 suspension for inhalation
TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor
Placebo Comparator: TQC3721 suspension placebo for inhalation
TQC3721 suspension placebo for inhalation, four weeks as a treatment cycle.
Drug: TQC3721 suspension placebo for inhalation
TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The peak of Forced Expiratory Volume(FEV1)
Time Frame: From the enrollment of the subjects to four weeks after administration
Change of the maximum value of FEV1 was determined from baseline to 30minute, 1hour, 2hour and 3hour after medication at week four
From the enrollment of the subjects to four weeks after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning trough FEV1
Time Frame: From the enrollment of the subjects to four weeks after administration
The FEV1 was determined before administration
From the enrollment of the subjects to four weeks after administration
Average FEV1
Time Frame: From the enrollment of the subjects to four weeks after administration
Average FEV1 twelve hours after administration
From the enrollment of the subjects to four weeks after administration
COPD Assessment Test (CAT)
Time Frame: From enrollment to four weeks after administration
Mean Change From Baseline in COPD Assessment Test (CAT) Scoring at Week four. The score range is zero to Fourty points (zero to ten is minor influence; eleven to twenty are moderate; twenty one to thirty are classified as severe impact; thirty one to forty is very severe), and more than ten is more symptoms.
From enrollment to four weeks after administration
Rescue medication
Time Frame: From baseline to four weeks after administration
Frequency of Rescue medication use during the study
From baseline to four weeks after administration
Incidence of adverse events
Time Frame: from baseline to four weeks after administration
The Incidence of adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events) v5.0
from baseline to four weeks after administration
Number of adverse events related to the study drug
Time Frame: from baseline to four weeks after administration
The number of adverse events associated with the study drug assessed by CTCAE V5.0
from baseline to four weeks after administration
Incidence of adverse events associated with the study drug
Time Frame: from baseline to four weeks after administration
Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0
from baseline to four weeks after administration

Collaborators and Investigators

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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)

May 20, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQC3721-II -01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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