A Phase 2 interventional study of TQC3927 inhalation aerosol and Glyceryl bromide/formoterol inhalation aerosol in Chronic Obstructive Pulmonary Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Suspended at 16 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days.
Drug: TQC3927 inhalation aerosol
The experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days.
Drug: TQC3927 inhalation aerosol
The positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days.
Drug: Glyceryl bromide/formoterol inhalation aerosol
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 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
This study is suspended, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.