A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease

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

Overview

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.

Interventions

• Drug TQC3927 inhalation aerosol
  TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
• Drug Glyceryl bromide/formoterol inhalation aerosol
  Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.

Primary outcome measures

• The area under the FEV1 curve (AUC) [Time frame: Within 14 days]

Secondary outcome measures (10)

• FEV1 peak [Time frame: Within 14 days]
• FEV1 morning valley value [Time frame: Within 14 days]
• The area under the FVC curve (AUC) [Time frame: Within 14 days]
• FEV1 [Time frame: Within 14 days]
• CAT rating [Time frame: Within 14 days]
• Scale for measuring dyspnea, cough, and sputum [Time frame: Within 14 days]
• Salbutamol Sulfate Inhalation Aerosol [Time frame: Within 14 days]
• Ctroμgh [Time frame: Within 14 days]
• Maximum mid-expiratory flow [Time frame: Within 14 days]
• Adverse events (AEs) [Time frame: Within 7 weeks]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 15 centers

• The First People' Hospital Of YuLin — Yulin
• Da Qing Long Nan Hospital — Daqing
• The People's Hospital of Anyang City — Anyang
• Yichang Central People's Hospital — Yichang
• Xiangtan County People's Hospital — Xiangtan
• Northern Jiangsu People's Hospital — Yangzhou
• Yixing People'S Hospital — Yixing
• Jiangxi Provincal People's Hospital — Nanchang
• … and 7 more centers

Identifiers

NCT: NCT07633314 · TQC3927-II-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗