Chronic Obstructive Pulmonary Disease
Conditions
Brief 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.
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
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
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the FEV1 curve (AUC) | Within 14 days | The area under the curve (AUC) of the change in FEV1 from baseline (ΔFEV1) 0-12 h after the first dose of Day 14. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 morning valley value | Within 14 days | 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). |
| The area under the FVC curve (AUC) | Within 14 days | 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. |
| FEV1 | Within 14 days | 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. |
| CAT rating | Within 14 days | Changes from baseline in Patient Self-Assessment Test (CAT) scores for D8 and D14 chronic obstructive pulmonary disease. |
| Scale for measuring dyspnea, cough, and sputum | Within 14 days | 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. |
| Salbutamol Sulfate Inhalation Aerosol | Within 14 days | Frequency and number of uses of the emergency medication salbutamol sulfate inhaler (Ventolin®) during a 2-week treatment period. |
| Ctroμgh | Within 14 days | 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. |
| Maximum mid-expiratory flow | Within 14 days | 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. |
| FEV1 peak | Within 14 days | Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14. |
| Adverse events (AEs) | Within 7 weeks | 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. |
Countries
China
Outcome results
None listed