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New inhaler shows promise for COPD in early trial

NCT ID NCT07252908

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested an experimental inhaled powder called TQC3721 in 195 people with moderate to severe COPD. The goal was to see if it improves lung function and is safe compared to a placebo. Researchers measured changes in breathing capacity over four weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TQC3721 inhalation powder
What this could lead to
If successful, this could lead to a new inhaled treatment option to help control COPD symptoms and improve lung function.
What could go wrong
This is an early-phase trial with only 195 participants, so results may not apply to everyone. The drug may not show meaningful benefit over placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

195 people

The number who actually took part.

Started

Dec 2025

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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). Exclusion Criteria: * 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. * 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: 1. Myocardial infarction, unstable angina, or stroke within the past 6 months; 2. Unstable or life-threatening arrhythmias requiring intervention within the past 3 months; 3. 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: 1. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2 × Upper Limit of Normal (ULN); alkaline phosphatase \> 2 × ULN; total bilirubin \> 1.5 × ULN; 2. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Affiliated Hospital Of ChengDu University

    Chengdu, Sichuan, 610081, China

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 610044, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

  • Guigang People's Hospital

    Guigang, Guangxi, 537100, China

  • Heze Municipal Hospital

    Heze, Shandong, 274000, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Jiujiang First People's Hospital

    Jiujiang, Jiangxi, 332000, China

  • Linfen People's Hospital

    Linfen, Shanxi, 41000, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000, China

  • Nuclear Industry 416 Hospital

    Chengdou, Sichuan, 610051, China

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001, China

  • Shanghai JiaoTong University of medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 20025, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Siping Central People's Hospital

    Siping, Jilin, 136099, China

  • Suining Central Hospital

    Suining, Sichuan, 629000, China

  • Taizhou central hospital (Taizhou university hospital)

    Taizhou, Zhejiang, 31800, China

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

    Wenzhu, Zhejiang, 325027, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010000, China

  • The Fourth Central Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300140, China

  • The People's Hospital of Liuyang

    Changsha, Hunan, 410000, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chognqing, 400010, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, Sichuan 610044, China

  • Xiangtan County People's Hospital

    Xiangtan, Hunan, 411200, China

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644000, China

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003, China

  • Yixing People'S Hospital

    Wuxi, Jiangsu, 214000, China

  • Zunyi Medical University Affiliated Hospital

    Zunyi, Guizhou, 563000, China

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Other studies related to the condition(s) this trial covers.