AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT05292196

A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

A Phase 2 study testing TQC3721 suspension for inhalation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TQC3721 suspension for inhalation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
11 sitesChina
Study dates
20 May 2022to 5 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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).

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730700

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621099

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jianxi, 330006

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110002

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

  • The Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524023

Other trials in China

About this study

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

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).

Being tested
TQC3721 suspension for inhalation, TQC3721 suspension placebo for inhalation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQC3721 suspension for inhalationDrug

    TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

  • TQC3721 suspension placebo for inhalationDrug

    TQC3721 suspension for inhalation is Dual PDE3/4 inhibitor

Study groups in NCT05292196
Study groupRoleWhat they receive
TQC3721 suspension for inhalationExperimentalTQC3721 suspension for inhalation, four weeks as a treatment cycle.
Receives: Drug: TQC3721 suspension for inhalation
TQC3721 suspension placebo for inhalationPlacebo comparatorTQC3721 suspension placebo for inhalation, four weeks as a treatment cycle.
Receives: Drug: TQC3721 suspension placebo for inhalation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From the enrollment of the subjects to four weeks after administration

Secondary outcomes (7)

  1. Morning trough FEV1

    The FEV1 was determined before administration

    Measured: From the enrollment of the subjects to four weeks after administration

  2. Average FEV1

    Average FEV1 twelve hours after administration

    Measured: From the enrollment of the subjects to four weeks after administration

  3. 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.

    Measured: From enrollment to four weeks after administration

  4. Rescue medication

    Frequency of Rescue medication use during the study

    Measured: From baseline to four weeks after administration

  5. Incidence of adverse events

    The Incidence of adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events) v5.0

    Measured: from baseline to four weeks after administration

  6. Number of adverse events related to the study drug

    The number of adverse events associated with the study drug assessed by CTCAE V5.0

    Measured: from baseline to four weeks after administration

  7. Incidence of adverse events associated with the study drug

    Incidence of adverse events associated with the study drug as assessed by CTCAE V5.0

    Measured: from baseline to four weeks after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start20 May 2022
  3. Primary completion11 Jan 2023
  4. Study completion5 Dec 2023

Why it stopped: Per sponsor request. Closure was not prompted by any safety or efficacy concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292196
Sponsor's protocol ID
TQC3721-II -01
Status last verified
Apr 2025
First submitted
15 Mar 2022
Last updated
20 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQC3721 suspension for inhalation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Per sponsor request. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The peak of Forced Expiratory Volume(FEV1) (time frame: From the enrollment of the subjects to four weeks after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in