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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 μg TQC3927 inhalation aerosol | Experimental | The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days. |
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| 600 μg TQC3927 inhalation aerosol | Experimental | The experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days. |
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| glycopyrronium bromide and formoterol inhaled aerosol | Active Comparator | The positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3927 inhalation aerosol | Drug | TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 peak | Changes in peak FEV1 from baseline after first administration on day 1, day 8, and day 14. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Yang, Doctor | Contact | 13651380809 | dryangting@qq.com | |
| Jintong Li, Doctor | Contact | 15300059186 | gcpljt@189.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People' Hospital Of YuLin | Yulin | Guangxi | 537000 | China |
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| Glyceryl bromide/formoterol inhalation aerosol | Drug | Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy. |
|
| 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. | 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. | Within 14 days |
| CAT rating | Changes from baseline in Patient Self-Assessment Test (CAT) scores for D8 and D14 chronic obstructive pulmonary disease. | 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. | 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. | 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. | 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. | 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. | Within 7 weeks |
| Da Qing Long Nan Hospital | Daqing | Heilongjiang | 163000 | China |
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| The People's Hospital of Anyang City | Anyang | Henan | 455099 | China |
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| Yichang Central People's Hospital | Yichang | Hubei | 443003 | China |
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| Xiangtan County People's Hospital | Xiangtan | Hunan | 411200 | China |
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| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225000 | China |
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| Yixing People'S Hospital | Yixing | Jiangsu | 214200 | China |
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| Jiangxi Provincal People's Hospital | Nanchang | Jiangxi | 330000 | China |
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| Siping Central People's Hospital | Siping | Jilin | 136099 | China |
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| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| Linfen Central Hospital | Linfen | Shanxi | 041099 | China |
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| Chengdu Third People's Hospital | Chengdu | Sichuan | 610031 | China |
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| The Fourth Central Hospital of Tianjin | Tianjin | Tianjin Municipality | 300140 | China |
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| The First Affiliated Hospital of Shihezi University Shihezi | Ürümqi | Xinjiang | 832008 | China |
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| The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU | Wenzhou | Zhejiang | 325027 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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