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.
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 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;
Parallel
TQC3927 inhalation aerosol
DrugTQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
Glyceryl bromide/formoterol inhalation aerosol
DrugGlycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.
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.
FEV1 peak
Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14.
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).
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.
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.
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