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SuspendedNCT07633314Updated Sep 3, 2026

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 interventional study of TQC3927 inhalation aerosol and Glyceryl bromide/formoterol inhalation aerosol in Chronic Obstructive Pulmonary Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Suspended at 16 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment

Why this study was suspended
The sponsor has decided to suspend study progress. Further implementation of the study is pending notification.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
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Study 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) characteristics of participants.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease
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In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    400 μg TQC3927 inhalation aerosol

    The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days.

    Drug: TQC3927 inhalation aerosol

  • Experimental
    600 μg TQC3927 inhalation aerosol

    The experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days.

    Drug: TQC3927 inhalation aerosol

  • Active comparator
    glycopyrronium bromide and formoterol inhaled aerosol

    The positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days.

    Drug: Glyceryl bromide/formoterol inhalation aerosol

Interventions

  • DrugTQC3927 inhalation aerosol

    TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).

  • DrugGlyceryl bromide/formoterol inhalation aerosol

    Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 14 days

Secondary outcomes

  1. FEV1 peak

    Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14.

    Time frame: Within 14 days

  2. 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).

    Time frame: Within 14 days

  3. 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.

    Time frame: Within 14 days

  4. 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.

    Time frame: Within 14 days

  5. CAT rating

    Changes from baseline in Patient Self-Assessment Test (CAT) scores for D8 and D14 chronic obstructive pulmonary disease.

    Time frame: Within 14 days

  6. 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.

    Time frame: Within 14 days

  7. Salbutamol Sulfate Inhalation Aerosol

    Frequency and number of uses of the emergency medication salbutamol sulfate inhaler (Ventolin®) during a 2-week treatment period.

    Time frame: Within 14 days

  8. 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.

    Time frame: Within 14 days

  9. 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.

    Time frame: Within 14 days

  10. 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.

    Time frame: Within 7 weeks

07

Study locations

16 sites
  • Peking University Shougang Hospital
    Beijing, Beijing Municipality 100144, China
  • The First People' Hospital Of YuLin
    Yulin, Guangxi 537000, China
  • Da Qing Long Nan Hospital
    Daqing, Heilongjiang 163000, China
  • The People's Hospital of Anyang City
    Anyang, Henan 455099, China
  • Yichang Central People's Hospital
    Yichang, Hubei 443003, China
  • Xiangtan County People's Hospital
    Xiangtan, Hunan 411200, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu 225000, China
  • Yixing People'S Hospital
    Yixing, Jiangsu 214200, China
  • Jiangxi Provincal People's Hospital
    Nanchang, Jiangxi 330000, China
  • Siping Central People's Hospital
    Siping, Jilin 136099, China
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
  • Linfen Central Hospital
    Linfen, Shanxi 041099, China
  • Chengdu Third People's Hospital
    Chengdu, Sichuan 610031, China
  • The Fourth Central Hospital of Tianjin
    Tianjin, Tianjin Municipality 300140, China
  • The First Affiliated Hospital of Shihezi University Shihezi
    Ürümqi, Xinjiang 832008, China
  • 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07633314
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Jun 8, 2026
Start date
Dec 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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