A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

NCT05292196 | Terminated Phase 2

• 1 other identifier: TQC3721-II -01
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Morning trough FEV1

  From the enrollment of the subjects to four weeks after administration

• Average FEV1

  From the enrollment of the subjects to four weeks after administration

• COPD Assessment Test (CAT)

  From enrollment to four weeks after administration

• Rescue medication

  From baseline to four weeks after administration

• Incidence of adverse events

  from baseline to four weeks after administration

Study Arms (2)

TQC3721 suspension for inhalation

EXPERIMENTAL

TQC3721 suspension for inhalation, four weeks as a treatment cycle.

Drug: TQC3721 suspension for inhalation

TQC3721 suspension placebo for inhalation

PLACEBO COMPARATOR

TQC3721 suspension placebo for inhalation, four weeks as a treatment cycle.

Drug: TQC3721 suspension placebo for inhalation

Interventions

TQC3721 suspension for inhalation DRUG

TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

TQC3721 suspension for inhalation

TQC3721 suspension placebo for inhalation DRUG

TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

TQC3721 suspension placebo for inhalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test;
• Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
• Aged between 18 and 75 years old, both men and women;
• Body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value) and body weight is ≥45kg;
• 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;
• 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;
• Ability to perform acceptable and reproducible spirometry;
• 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;
• 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;
• 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;
• 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).

You may not qualify if:

• Intolerance to salbutamol or this product.
• ≥1 hospitalization for COPD treatment within 6 months prior to screening.
• Antibiotic treatment for lower respiratory tract infection within 3 months prior to screening.
• Use of prohibited medications within the time intervals.
• Patients who were currently diagnosed with asthma, active tuberculosis, lung cancer and other active lung diseases and were considered unsuitable for the study.
• Previous lung resection or lung reduction surgery.
• Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
• 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).
• 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.
• Women who are breast-feeding.
• 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.
• 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.
• Required use of oxygen therapy, even on an occasional basis.
• Other conditions that the investigator considered inappropriate for participation in the study.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (11)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730700, China

Location

The Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524023, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jianxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: May 20, 2022
• Primary Completion: January 11, 2023
• Study Completion: December 5, 2023
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

CN (11)