Chronic Obstructive Pulmonary DiseasePhase 2NCT07633314
A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease
A Phase 2 study testing TQC3927 inhalation aerosol and Glyceryl bromide/formoterol inhalation aerosol in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial summary
This is a multicenter, randomized, open-label, positive-drug controlled study designed to evaluate the preliminary efficacy and safety of different doses of TQC3927 inhaled powder for short-term treatment of patients with chronic obstructive pulmonary disease, and to observe the symptoms and pharmacokinetic (PK)… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3927 inhalation aerosol and Glyceryl bromide/formoterol inhalation aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 16 sitesChina
- Study dates
- Dec 2026to Jan 2027
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
The People's Hospital of Anyang City
Anyang, Henan, 455099
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Chengdu Third People's Hospital
Chengdu, Sichuan, 610031
Da Qing Long Nan Hospital
Daqing, Heilongjiang, 163000
Linfen Central Hospital
Linfen, Shanxi, 041099
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, 330000
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Siping Central People's Hospital
Siping, Jilin, 136099
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300140
The First Affiliated Hospital of Shihezi University Shihezi
Ürümqi, Xinjiang, 832008
The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325027
Xiangtan County People's Hospital
Xiangtan, Hunan, 411200
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Yichang Central People's Hospital
Yichang, Hubei, 443003
Yixing People'S Hospital
Yixing, Jiangsu, 214200
The First People' Hospital Of YuLin
Yulin, Guangxi, 537000
About this study
Official title: A Multicenter, Randomized, Open-label, Active-controlled Phase II Clinical Trial to Explore the Efficacy and Safety of Different Doses of TQC3927 Inhaled Powder in Patients With Chronic Obstructive Pulmonary Disease
This is a multicenter, randomized, open-label, positive-drug controlled study designed to evaluate the preliminary efficacy and safety of different doses of TQC3927 inhaled powder for short-term treatment of patients with chronic obstructive pulmonary disease, and to observe the symptoms and pharmacokinetic (PK) characteristics of participants.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC3927 inhalation aerosol, Glyceryl bromide/formoterol inhalation aerosol
- 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.
TQC3927 inhalation aerosolDrug
TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
Glyceryl bromide/formoterol inhalation aerosolDrug
Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| 400 μg TQC3927 inhalation aerosol | Experimental | The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days. Receives: Drug: TQC3927 inhalation aerosol |
| 600 μg TQC3927 inhalation aerosol | Experimental | The experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days. Receives: Drug: TQC3927 inhalation aerosol |
| glycopyrronium bromide and formoterol inhaled aerosol | Active comparator | The positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days. Receives: Drug: Glyceryl bromide/formoterol inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the FEV1 curve (AUC)
The area under the curve (AUC) of the change in FEV1 from baseline (ΔFEV1) 0-12 h after the first dose of Day 14.
Measured: Within 14 days
Secondary outcomes (10)
FEV1 peak
Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14.
Measured: Within 14 days
FEV1 morning valley value
Changes from baseline in FEV1 morning trough values at Day 2, D8 before the first dose, and 12 hours after the second dose on Day 14 (Day 15).
Measured: Within 14 days
The area under the FVC curve (AUC)
The areas under the curve (AUC) of FEV1 and FVC changes from baseline (ΔFEV1 and ΔFVC) at 0-6 hour, 0-8 hour, and 0-12 hour after the first dose of D1; the areas under the curve (AUC) of FEV1 changes from baseline (ΔFEV1) and FVC changes from baseline (ΔFVC) at 0-6 hour, 0-8 hour, and 0-12 hour after the first dose of Day 14.
Measured: Within 14 days
FEV1
The change in FEV1 from baseline at each time point within 12 hours after the first dose on Day 1 and the first dose on Day 14.
Measured: Within 14 days
CAT rating
Changes from baseline in Patient Self-Assessment Test (CAT) scores for D8 and D14 chronic obstructive pulmonary disease.
Measured: Within 14 days
Scale for measuring dyspnea, cough, and sputum
Changes in the total score and individual item scores of the Dyspnea, Cough and Sputum Scale (BCSS) from baseline at each time point from Day 1 to Day 7, Day 8 to Day 14, and Day 1 to Day 14.
Measured: Within 14 days
Salbutamol Sulfate Inhalation Aerosol
Frequency and number of uses of the emergency medication salbutamol sulfate inhaler (Ventolin®) during a 2-week treatment period.
Measured: Within 14 days
Ctroμgh
Ctroμgh: Blood drug concentration at the end of the dosing interval (before the next dose); PK: The entire process of absorption, distribution, metabolism, and excretion in the body, and the pattern of blood drug concentration changes over time.
Measured: Within 14 days
Maximum mid-expiratory flow
Changes in maximum mid-expiratory flow (MMEF) from baseline at each time point after the first dose on day 1, day 8, and day 14.
Measured: Within 14 days
Adverse events (AEs)
Adverse events (AEs) refer to all adverse medical events that occur after a participant receives the investigational drug. These can manifest as symptoms, signs, illnesses, or abnormal laboratory tests, but are not necessarily causally related to the investigational drug.
Measured: Within 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: The sponsor has decided to suspend study progress. Further implementation of the study is pending notification.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633314
- Sponsor's protocol ID
- TQC3927-II-01
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No