AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 2NCT07252908

A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder

A Phase 2 study testing TQC3721 inhalation powder in people with Pulmonary Disease, Chronic Obstructive, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 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 inhalation powder 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?
TQC3721 inhalation powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
29 sitesChina
Study dates
22 Dec 2025to 7 May 2026
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 the informed consent form before the trial and have a full understanding of the trial content, process, and potential adverse reactions.
  • Be willing and able to adhere to the trial visit schedule and procedures and use the dry powder inhaler correctly.
  • Male and female subjects aged 40 to 80 years (inclusive).
  • Body Mass Index (BMI) within the range of 18-30 kg/m² (inclusive).
  • Subjects have no plans for pregnancy and voluntarily adopt effective contraceptive measures from screening to at least 1 month after the last use of the study drug.
  • 12-lead electrocardiogram (ECG) showing: heart rate of 50-100 beats per minute (bpm); corrected QT interval (QTcF) <= 450 msec for males or <= 470 msec for females.
Show all 14Show fewer
  • Diagnosed with COPD according to the 2025 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, and have had symptoms consistent with COPD for at least 1 year before screening.
  • Have been on stable background inhaled therapy for COPD for at least 4 weeks before screening.
  • Be able to perform acceptable and reproducible pulmonary function tests.
  • At the screening visit (V1 visit), after administration of a bronchodilator (4 puffs of salbutamol), the FEV1/Forced Vital Capacity (FVC) ratio < 0.7, and 30% predicted value <= FEV1 < 80% predicted value.
  • Clinically stable COPD within 4 weeks before the screening visit (V1 visit) and between the V1 visit and V2 visit.
  • Modified Medical Research Council (mMRC) Dyspnea Scale score >= 2 at screening.
  • Meet the concurrent medication restrictions (within the time intervals specified in the protocol) and are expected to maintain the restriction requirements during treatment.
  • Smoking history >= 10 pack-years (pack-year: number of packs per day × number of smoking years; e.g., 1 pack (20 cigarettes) per day for 10 consecutive years, or 10 cigarettes per day for 20 consecutive years).

Who cannot join

  • Life-threatening COPD history, including admission to the intensive care unit (ICU) and/or requirement for intubation.
  • COPD exacerbation requiring systemic corticosteroid therapy within 3 months before the screening visit (V1 visit) or before the randomization visit (V2 visit).
  • Hospitalization history due to COPD or pneumonia ≥ 1 time within 6 months before screening.
  • Antibiotic treatment for upper and/or lower respiratory tract infections within 6 weeks before screening or before the randomization visit (V3 visit). Note: Subjects with a history of lower respiratory tract infection within 6 weeks cannot be enrolled, but may be rescreened 6 weeks after recovery from the infection.
  • Concurrent other respiratory diseases: α-1 antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; clinically significant active pulmonary infections, pulmonary tuberculosis, bronchiectasis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, asthma, and other respiratory diseases as assessed by the investigator.
  • Clinically significant abnormalities found on chest computed tomography (CT) that are not caused by COPD and judged by the investigator to have an impact on trial results or patient safety. If there is no chest CT report within 6 months before Visit 1, a chest CT examination must be performed at Visit 1.
Show all 33Show fewer
  • Previous pulmonary resection or lung volume reduction surgery.
  • Pulmonary rehabilitation therapy (those whose treatment has been stable for 4 weeks before screening and will remain stable during the trial may be enrolled).
  • Receipt of oral corticosteroids or roflumilast for COPD within 3 months before the screening visit (V1 visit), or receipt of oral theophylline and/or theophylline derivatives for COPD within 1 week before the screening visit (V1 visit).
  • Use of non-selective oral beta-blockers.
  • Previous treatment with TQC3721.
  • Patients who received immunotherapy (e.g., azathioprine, cyclophosphamide) within 4 weeks before the screening period.
  • As assessed by the investigator, the patient cannot discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of this study.
  • The patient has a history of currently uncontrolled diseases, including but not limited to endocrine, thyroid, neuropsychiatric, hepatic, gastrointestinal, renal, hematologic, urinary, immunologic, or ophthalmic diseases, which are judged to be clinically significant by the investigator.
  • History or current evidence of clinically significant cardiovascular diseases, defined as any disease that the investigator believes would endanger the patient's safety if participating in the study, or any disease that may affect the efficacy or safety analysis if the disease/condition deteriorates during the study; subjects with any of the following conditions at Visit 1 will be excluded:
  • Myocardial infarction, unstable angina, or stroke within the past 6 months;
  • Unstable or life-threatening arrhythmias requiring intervention within the past 3 months;
  • New York Heart Association (NYHA) Class III-IV heart failure.
  • Unstable or uncontrolled hypertension (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 100 mmHg after drug control).
  • Patients with poorly controlled type 2 diabetes or fasting blood glucose > 10 mmol/L.
  • Receipt of major surgery (requiring general anesthesia) within 8 weeks before the screening visit (V1 visit), failure to fully recover from the surgery at the time of screening (V1 visit), or planned surgery before the end of the study.
  • History of malignant tumors (cured or uncured) of any organ or system within the past 5 years (excluding non-metastatic cutaneous basal cell or squamous cell carcinoma, or cervical carcinoma in situ that have been cured for more than 5 years before the screening period).
  • Clinically significant abnormal values in safety laboratory tests (hematology, biochemistry, or urinalysis) determined by the investigator at the screening visit (V1 visit), including but not limited to one of the following:
  • Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 2 × Upper Limit of Normal (ULN); alkaline phosphatase > 2 × ULN; total bilirubin > 1.5 × ULN;
  • Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 60 mL/min/1.73m².
  • Positive test result for Human Immunodeficiency Virus (HIV) antibody; positive test result for Hepatitis B Surface Antigen (HBsAg) (if HBsAg is positive, Hepatitis B Virus (HBV) DNA testing may be added if necessary; subjects with HBV DNA < Lower Limit of Quantification (LLOQ) need not be excluded); positive Hepatitis C Virus (HCV) antibody with confirmed presence of HCV ribonucleic acid (RNA); positive Treponema Pallidum Particle Agglutination (TPPA) antibody.
  • Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD.
  • Patients requiring continuous or intermittent oxygen therapy.
  • Female subjects who are pregnant, lactating, or planning to become pregnant during the study enrollment period.
  • Receipt of live attenuated vaccine within 28 days before randomization, receipt of inactivated vaccine within 7 days before randomization, or planned vaccination during the study.
  • History of drug abuse or alcoholism within the past 3 years (consumption of 14 units of alcohol per week: 1 unit = 360 ml of beer, or 45 ml of spirits with 40% alcohol content, or 150 ml of wine).
  • Participation in any drug or medical device clinical trial within 4 weeks or 5 drug half-lives (whichever is longer) before screening.
  • Other conditions deemed unsuitable for study participation by the investigator.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • The People's Hospital of Liuyang

    Changsha, Hunan, 410000

  • Nuclear Industry 416 Hospital

    Chengdou, Sichuan, 610051

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 610044

  • Affiliated Hospital Of ChengDu University

    Chengdu, Sichuan, 610081

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, Sichuan 610044

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chognqing, 400010

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Guigang People's Hospital

    Guigang, Guangxi, 537100

  • Heze Municipal Hospital

    Heze, Shandong, 274000

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000

  • Jiujiang First People's Hospital

    Jiujiang, Jiangxi, 332000

  • Linfen People's Hospital

    Linfen, Shanxi, 41000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 20025

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Siping Central People's Hospital

    Siping, Jilin, 136099

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Taizhou central hospital (Taizhou university hospital）

    Taizhou, Zhejiang, 31800

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The Fourth Central Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300140

  • The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU

    Wenzhu, Zhejiang, 325027

  • Yixing People'S Hospital

    Wuxi, Jiangsu, 214000

  • Xiangtan County People's Hospital

    Xiangtan, Hunan, 411200

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644000

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003

  • 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 to Evaluate the Efficacy and Safety of TQC3721 Inhalation Powder in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

To evaluate the efficacy and safety of TQC3721 inhalation powder in patients with moderate to severe Chronic obstructive pulmonary disease (COPD).

Being tested
TQC3721 inhalation powder, Placebo for TQC3721 inhalation powder
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 inhalation powderDrug

    TQC3721 inhalation powder is target inhibitor.

  • Placebo for TQC3721 inhalation powderDrug

    Placebo for TQC3721 inhalation powder.

Study groups in NCT07252908
Study groupRoleWhat they receive
750 µg Dosage groupExperimental750 µg TQC3721 inhalation powder，administered by inhalation，twice a day for 4 weeks.
Receives: Drug: TQC3721 inhalation powder
1000 µg Dosage groupExperimental1000µg TQC3721 inhalation powder，administered by inhalation，twice a day for 4 weeks.
Receives: Drug: TQC3721 inhalation powder
Placebo for TQC3721 inhalation powderPlacebo comparatorPlacebo for TQC3721 inhalation powder, administered by inhalation, twice a day for 4 weeks.
Receives: Drug: Placebo for TQC3721 inhalation powder

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 (11)

  1. Number of subjects of changes in the peak, trough values of FEV1 and average FEV1 AUC

    Number of subjects of changes in the peak, trough values of FEV1 and average FEV1 Area under the curve (AUC) within 3 hours and 12 hours after morning administration on 1 day, 2 weeks and 4 weeks of treatment compared with the baseline.

    Measured: From baseline to four weeks after treatment

  2. Valley concentration

    Evaluating valley concentration of TQC3721 (in selected patients only).

    Measured: From baseline to four weeks after treatment

  3. Adverse Events (AE)

    The subjets with 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)

  4. Frequency of rescue medication used during the study

    Frequency of rescue medication used during the study compared to placebo group

    Measured: From baseline to four weeks after administration

  5. Changes in Chronic obstructive pulmonary disease Assessment Test (CAT)

    Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline.The CAT questionnaire is mainly used to assess the impact of COPD on patients' health and daily quality of life.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: From baseline to four weeks after treatment

  6. Changes in St. George's Respiratory Questionnaire (SGRQ)

    Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline. The SGRQ is a standardized self-assessment tool used to evaluate the quality of life of patients with chronic respiratory diseases. It quantifies the degree of impairment in patients' symptoms, activity capacity and social psychological adaptation, and comprehensively reflects the impact of the disease on patients' daily lives.

    Measured: From baseline to four weeks after treatment

  7. Peak concentration

    Evaluating peak concentration of TQC3721 (in selected patients only)

    Measured: From baseline to four weeks after treatment

  8. Area under the concentration-time curve from 0 to last observation (AUC 0-t) of TQC3721

    Evaluating Area under the concentration-time curve from 0 to last observation (AUC 0-t) of TQC3721. (in selected patients only)

    Measured: From baseline to four weeks after treatment

  9. Apparent volume of distribution (Vd/F)

    Evaluating Vd/F of TQC3721. (in selected patients only)

    Measured: From baseline to four weeks after treatment

  10. Apparent clearance (CL/F)

    Evaluating Apparent clearance (CL/F) of TQC3721. (in selected patients only)

    Measured: From baseline to four weeks after treatment

  11. Half-ife (t1/2)

    Evaluating the time required for half of the drug to be eliminated from the plasma of TQC3721. (in selected patients only)

    Measured: From baseline to four weeks after treatment

Timeline

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

  1. First posted28 Nov 2025
  2. Study start22 Dec 2025
  3. Primary completion28 Apr 2026
  4. Study completion7 May 2026

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
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252908
Sponsor's protocol ID
TQC3721-D8-II-01
Status last verified
Jan 2026
First submitted
19 Nov 2025
Last updated
18 Jun 2026
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 inhalation powder in people with Pulmonary Disease, Chronic Obstructive, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 29 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 14 inclusion and 33 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 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 NCT07252908.

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 18 Jun 2026.

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