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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.
The First People' Hospital Of YuLin
Yulin, Guangxi, China
Da Qing Long Nan Hospital
Daqing, Heilongjiang, China
The People's Hospital of Anyang City
Anyang, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
Xiangtan County People's Hospital
Xiangtan, Hunan, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Yixing People'S Hospital
Yixing, Jiangsu, China
Jiangxi Provincal People's Hospital
Nanchang, Jiangxi, China
Siping Central People's Hospital
Siping, Jilin, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
...and 5 more locations
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
FEV1 peak
Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14.
Time frame: Within 14 days
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
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
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
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
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
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
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
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
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
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