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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.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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
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 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

Other trials in China

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.

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 groups in NCT07633314
Study groupRoleWhat they receive
400 μg TQC3927 inhalation aerosolExperimentalThe 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 aerosolExperimentalThe 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 aerosolActive comparatorThe 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.

  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.

    Measured: Within 14 days

Secondary outcomes (10)

  1. FEV1 peak

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

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Within 14 days

  5. CAT rating

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    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.

  1. First posted8 Jun 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Why it stopped: The sponsor has decided to suspend study progress. Further implementation of the study is pending notification.

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
None (open label)
Enrolment
90 participants (estimated)
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

Questions about this trial

What is this clinical trial studying?

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.

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 10 inclusion and 26 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: paused, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. 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?

Results are not available in the source record.

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?

The area under the FEV1 curve (AUC) (time frame: Within 14 days). 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 NCT07633314.

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 3 Sep 2026.

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