AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 2NCT06527144

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

A Phase 2 study testing 3mg TQC3721 Suspension for Inhalation and 6mg TQC3721 Suspension for Inhalation in people with Pulmonary Disease, Chronic Obstructive, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD) Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
3mg TQC3721 Suspension for Inhalation and 6mg TQC3721 Suspension for Inhalation
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
28 sitesChina
Study dates
14 Sep 2024to 6 Mar 2025
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign informed consent before the test and fully understand the test content, process and possible adverse reactions.
  • Male and female subjects aged 40 to 80 years old (including the cut-off value).
  • Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
  • Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
  • Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
  • Able to conduct acceptable and reproducible lung function tests.
  • COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
  • Smoking history ≥ 10 pack years.

Who cannot join

  • History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
  • Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
  • Screening for hospitalization history due to COPD within the first 6 months.
  • Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
  • Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
  • Previous lung resection or lung reduction surgery.
Show all 18Show fewer
  • Pulmonary rehabilitation treatment.
  • Previously received TQC3721 treatment.
  • Patients who received immunotherapy within the first 4 weeks of the screening period.
  • The patient has a history of diseases that are currently beyond their control.
  • History or current evidence of cardiovascular disease with clinical significance.
  • History of cured or untreated malignant tumors in any organ or system within the past 5 years.
  • Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
  • Those who require oxygen therapy or intermittent oxygen therapy.
  • Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
  • Planned vaccine recipients during the period.
  • Individuals who have participated in any drug or medical device clinical trials prior to screening.
  • Researchers believe that there are other situations that are not suitable for participation in the study.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Cangzhou Hospital of Integrated Tcm-Wm·Hebei

    Cangzhou, Hebei, 61012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130031

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 024000

  • ChongQing University Fuling Hospital

    Chongqing, Chongqing Municipality, 400000

  • Fu Yang People'S Hospital

    Fuyang, Anhui, 236000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Heze Municipal Hospital

    Heze, Shandong, 274031

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530016

  • Genertec Liaoyou Gem Flower Hospital

    Panjin, Liaoning, 100007

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 20025

  • Shangqiu First People's Hospita

    Shangqiu, Henan, 476000

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang, 832000

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Siping Central People's Hospital

    Siping, Jilin, 136099

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300041

  • TianJin 4th Center Hospital

    Tianjin, Tianjin Municipality, 300142

  • Wenzhou University Affiliated Second Hospital

    Wenzhou, Zhejiang, 325027

  • Wuxi Fifth People's Hospital

    Wuxi, Jiangsu, 214000

  • Yixing People'S Hospital

    Wuxi, Jiangsu, 214200

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian, 361021

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)

Being tested
3mg TQC3721 Suspension for Inhalation, 6mg TQC3721 Suspension for Inhalation, Placebo TQC3721 suspension 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.

  • 3mg TQC3721 Suspension for InhalationDrug

    TQC3721 suspension for inhalation is target inhibitor.

  • 6mg TQC3721 Suspension for InhalationDrug

    TQC3721 suspension for inhalation is target inhibitor.

  • Placebo TQC3721 suspension for inhalationDrug

    Placebo without active drug substance.

Study groups in NCT06527144
Study groupRoleWhat they receive
3mg TQC3721 Suspension for Inhalation (Twice a day)ExperimentalTwo syringes of TQC3721 suspension for inhalation (1ml:1.5mg), twice a day for 4 weeks.
Receives: Drug: 3mg TQC3721 Suspension for Inhalation
6mg TQC3721 Suspension for Inhalation (Twice a day)Experimentalone syringe of TQC3721 suspension for inhalation（1ml:6mg）and one TQC3721 suspension placebo for inhalation (1ml:0mg), twice a day for 4 weeks.
Receives: Drug: 6mg TQC3721 Suspension for Inhalation
Placebo for TQC3721 Suspension for Inhalation (Twice a day)Placebo comparatorTwo syringes of placebo for TQC3721 suspension for inhalation (1ml:0mg), twice a day for 4 weeks.
Receives: Drug: Placebo TQC3721 suspension for inhalation

What is being measured

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

  1. Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)

    Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment.

    Measured: From baseline to four weeks after treatment

Secondary outcomes (13)

  1. Change of the mean value of FEV1

    Compared with baseline, the mean value of FEV1 was changed within 3 hours and 12 hours after morning medication at 4 weeks of treatment.

    Measured: From baseline to four weeks after treatment

  2. Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration

    Compared with baseline, Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration after 2 weeks of treatment.

    Measured: From baseline to two weeks after treatment

  3. Rescue medication

    Frequency of Rescue medication use during the study compared to placebo group

    Measured: From baseline to four weeks after administration

  4. Adverse Events (AE)

    The number, frequency, incidence, and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated.

    Measured: From baseline to safety visit (about 5 weeks after first dosing).

  5. Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration

    Compared with baseline, changes in the peak value of FEV1 after 1 day of treatment, and the mean value of FEV1 within 3 hours and 12 hours after administration.

    Measured: From baseline to 1day after treatment

  6. Changes of FEV1 at each time point

    Changes in series FEV1 at each time point within 12 hours after morning administration on day 1 of treatment (after first dosing) compared to baseline.

    Measured: From baseline to 1day after treatment

  7. Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours

    To evaluate the change in FEV1 peak value and FEV1 mean value within 3 hours and 12 hours after 4 weeks of treatment compared with 1 day of treatment (after first administration)

    Measured: From 1day after treatment to 4 weeks after treatment

  8. Changes in Morning Valley FEV1

    Changes in Morning Valley FEV1 after 4 weeks of treatment compared with baseline

    Measured: From baseline to four weeks after treatment

  9. Changes in Modified Medical Research Council (mMRC) Dyspnea Scale Score

    mMRC Dyspnea Scale Score's total score is 0-4 points, with the higher score meaning the more severe symptoms.

    Measured: Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline

  10. Chronic obstructive pulmonary disease Assessment Test (CAT)

    There are 8 questions in the CAT, and each question is scored 0-5 points, with the higher score meaning the more severe symptoms

    Measured: Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline

  11. St. George's Respiratory Questionnaire (SGRQ)

    SGRQ has three parts: symptoms, abilities, and effects, and is used to comprehensively measure the physical, mental, and social status of COPD patients.

    Measured: Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline

  12. Basic Dyspnea Index (BDI)

    BDI has three levels: functional impairment, magnitude of task, and magnitude of effort. Each level is rated from 0 (severe) to 4(No damage).

    Measured: Changes in BDI after 2 and 4 weeks of treatment compared with baseline.

  13. Transitional Dyspnea Index (TDI)

    TDI has three levels:changes in functional impairment, changes in magnitude of task, changes in magnitude of effort,. Scores in each area range from -3 (significant deterioration) to 0 (no change) to +3 (significant improvement).

    Measured: Changes in TDI after 2 and 4 weeks of treatment compared with baseline

Timeline

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

  1. First posted30 Jul 2024
  2. Study start14 Sep 2024
  3. Primary completion16 Jan 2025
  4. Study completion6 Mar 2025

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
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06527144
Sponsor's protocol ID
TQC3721-II-03
Status last verified
May 2024
First submitted
24 Jul 2024
Last updated
11 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • He LX, Yang L, Xiao ZK, Qiu R, Yu FM, Wu LQ, Zhang WH, Liu XC, Min LF, Ma XQ, Jiang JZ, Yuan B, Dai RR, Liu D, Li XH, Wang T, Cao J, Luo XB, Liu XJ, Chen C, Li WG, Yu D, Luo Z, Li WM; PACER-II Trial Investigators. Effects of a Novel Dual Phosphodiesterase 3 and 4 Inhibitor TQC3721 in Patients With COPD in China (PACER-II): A Phase 2, Multicenter, Randomized, Double-Anonymized, Placebo-Controlled Trial. Chest. 2026 Jun;169(6):1536-1550. doi: 10.1016/j.chest.2025.12.055. Epub 2026 Mar 3.

    PubMed 41812987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3mg TQC3721 Suspension for Inhalation and 6mg TQC3721 Suspension for Inhalation in people with Pulmonary Disease, Chronic Obstructive, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 28 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 8 inclusion and 18 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: finished, as of the sponsor's last update on 11 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 28 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change of the maximum value of Forced Expiratory Volume in the first second (FEV1) (time frame: From baseline to four weeks after treatment). 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 NCT06527144, which also lists 1 linked publication.

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 11 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