A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292196
• Other study ID #: TQC3721-II -01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2022
• Est. completion date: May 2024

Study information

• Verified date: June 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Weimin Li, Doctor
• Phone: 028-85423837
• Email: llllllv2[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• TQC3721 suspension for inhalation
TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor
• TQC3721 suspension placebo for inhalation
TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Fourth Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jianxi
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	The Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The peak of Forced Expiratory Volume(FEV1)	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	Morning trough FEV1	The FEV1 was determined before administration	From the enrollment of the subjects to four weeks after administration
Secondary	Average FEV1	Average FEV1 twelve hours after administration	From the enrollment of the subjects to four weeks after administration
Secondary	COPD Assessment Test (CAT)	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
Secondary	Rescue medication	Frequency of Rescue medication use during the study	From baseline to four weeks after administration
Secondary	Incidence of adverse events	The Incidence of adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events) v5.0	from baseline to four weeks after administration
Secondary	Number of adverse events related to the study drug	The number of adverse events associated with the study drug assessed by CTCAE V5.0	from baseline to four weeks after administration
Secondary	Incidence of adverse events associated with the study drug	Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0	from baseline to four weeks after administration