New COPD inhaler shows promise in early trial
NCT ID NCT07633314
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests a new inhaled powder called TQC3927 for people with chronic obstructive pulmonary disease (COPD). The goal is to see if different doses can improve lung function and are safe over a short treatment period. About 90 adults aged 40 to 75 with COPD will take part. The study compares TQC3927 to an existing active drug to measure its effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 an informed consent form before the trial to fully understand the purpose, procedure, and possible adverse reactions; * Age: 40 years ≤ age ≤ 75 years (calculated from the date of signing the informed consent form), gender not limited; * Participants' body mass index (BMI) is within the range of 18\~30 kg/m2 (including the borderline), and their weight is ≥45kg; * Diagnosed with Chronic Obstructive Lung Disease (COPD) according to the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, and symptoms consistent with COPD for at least 1 year before the screening visit (V1); * Participants must have discontinued short-acting β2-adrenergic receptor agonist (SABA) for at least 6 hours and short-acting cholinergic receptor antagonist (SAMA) for at least 8 hours before starting any pulmonary function tests; * Participants must be current or former smokers with a smoking history of ≥10 pack-years (pack-year: number of packs per day × number of years of smoking, such as 1 pack of 20 cigarettes per day for 10 consecutive years, or 10 cigarettes per day for 20 consecutive years); former smokers are defined as those who have quit smoking for at least 6 months prior to Visit 1. Note: Use of pipes, cigars, and e-cigarettes cannot be used to calculate packs/year; * Trained participants are able to perform acceptable and reproducible pulmonary function tests according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 criteria; * Participants voluntarily sign informed consent forms and have no plans for pregnancy within 90 days from the start of treatment to the last dose, and voluntarily use medically approved contraception (including with their partners); * Trained participants are able to correctly use a pressure metered-dose inhaler (pMDI), dry powder inhaler (DPI) inhaler for drug administration; * Participants are able to attend study visits on time and complete the visit content; Exclusion Criteria: * Participants currently diagnosed with asthma (including asthma with COPD) or with a history of asthma, based on the investigator's judgment; * Participants with a current life-threatening COPD history; * Participants with concurrent active or clinically significant respiratory illnesses that significantly impact the study; * Participants with serious illnesses other than COPD, or abnormalities in laboratory tests, electrocardiograms, medical history, or physical examinations; * Participants who have undergone lung volume reduction surgery, lobectomy/segmentectomy, or are expected to undergo lung surgery during the study period within 12 months prior to V1; * Participants who have developed pneumonia or lower respiratory tract infections requiring antibiotic treatment within 8 weeks prior to V1 or between V1 and V3; * Participants with clinically significant abnormalities on chest computed tomography (CT); * Participants currently using positive pressure ventilation; * Participants requiring long-term oxygen therapy (oxygen therapy time \> 15 minutes). 10. Individuals undergoing pulmonary rehabilitation; * Participants who changed their smoking status (i.e., started or stopped smoking) or began a smoking cessation program within 6 weeks prior to screening; * Individuals with unstable or life-threatening heart disease; * Individuals using non-selective oral beta-blockers; * Individuals with unstable or uncontrolled hypertension; * Abnormal values in clinically significant safety laboratory tests determined by the investigator at the screening visit; * Positive results for human immunodeficiency virus (HIV); positive results for hepatitis B surface antigen (HBsAg); positive results for hepatitis C virus (HCV) antibody and supporting documentation. * Individuals with a confirmed history of neurological or psychiatric disorders, including epilepsy or dementia requiring treatment; * Individuals with a history or current condition of neuropsychiatric, respiratory, cardiovascular, digestive, hematopoietic, lymphatic, immune, hepatic or renal insufficiency, endocrine, musculoskeletal, or other diseases; * Individuals who have participated in any drug or medical device clinical trial and received a study intervention within 4 weeks or 5 drug half-lives (whichever is longer) prior to screening; * Individuals who have lost or donated more than 400 ml of blood within 3 months prior to the trial. 21. Individuals with a known history of drug or food allergies, especially to components similar to the investigational drug; * Individuals who have frequently consumed alcohol within the 6 months prior to screening, or who have tested positive for alcohol in a breathalyzer test; * Individuals who have received a live attenuated vaccine within 28 days prior to randomization, an inactivated vaccine within 7 days prior to randomization, or are scheduled to receive a vaccine during the study period; * Individuals with a history of any organ or systemic malignancy within the past 5 years; * Individuals with a history of drug abuse within the past 2 years, or who have tested positive for drug abuse; * Individuals assessed by the investigators as unable to discontinue prohibited drugs as specified in the protocol during the screening and treatment phases of this study; * Pregnant or lactating women, or female participants with positive pregnancy test results; * Individuals with difficulty obtaining venous blood or a history of fainting from needles or blood loss;
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chengdu Third People's Hospital
Chengdu, Sichuan, 610031, China
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Da Qing Long Nan Hospital
Daqing, Heilongjiang, 163000, China
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Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000, China
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Linfen Central Hospital
Linfen, Shanxi, 041099, China
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Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000, China
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Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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Siping Central People's Hospital
Siping, Jilin, 136099, China
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The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325027, China
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The First Affiliated Hospital of Shihezi University Shihezi
Ürümqi, Xinjiang, 832008, China
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The First People' Hospital Of YuLin
Yulin, Guangxi, 537000, China
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The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300140, China
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The People's Hospital of Anyang City
Anyang, Henan, 455099, China
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Xiangtan County People's Hospital
Xiangtan, Hunan, 411200, China
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Yichang Central People's Hospital
Yichang, Hubei, 443003, China
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Yixing People'S Hospital
Yixing, Jiangsu, 214200, China
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