Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Interventions
DRUG3mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
DRUG6mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
DRUGPlacebo TQC3721 suspension for inhalation
Placebo without active drug substance.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Sign informed consent before the test and fully understand the test content, process and possible adverse reactions. * Male and female subjects aged 40 to 80 years old (including the cut-off value). * Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value) * Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug. * Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria. * Able to conduct acceptable and reproducible lung function tests. * COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit. * Smoking history ≥ 10 pack years.
Exclusion criteria
* History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation. * Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit. * Screening for hospitalization history due to COPD within the first 6 months. * Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit. * Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD. * Previous lung resection or lung reduction surgery. * Pulmonary rehabilitation treatment. * Previously received TQC3721 treatment. * Patients who received immunotherapy within the first 4 weeks of the screening period. * The patient has a history of diseases that are currently beyond their control. * History or current evidence of cardiovascular disease with clinical significance. * History of cured or untreated malignant tumors in any organ or system within the past 5 years. * Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit. * Those who require oxygen therapy or intermittent oxygen therapy. * Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study. * Planned vaccine recipients during the period. * Individuals who have participated in any drug or medical device clinical trials prior to screening. * Researchers believe that there are other situations that are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the maximum value of Forced Expiratory Volume in the first second (FEV1) | From baseline to four weeks after treatment | Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration | From baseline to two weeks after treatment | Compared with baseline, Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration after 2 weeks of treatment. |
| Rescue medication | From baseline to four weeks after administration | Frequency of Rescue medication use during the study compared to placebo group |
| Adverse Events (AE) | From baseline to safety visit (about 5 weeks after first dosing). | The number, frequency, incidence, and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated. |
| Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration | From baseline to 1day after treatment | Compared with baseline, changes in the peak value of FEV1 after 1 day of treatment, and the mean value of FEV1 within 3 hours and 12 hours after administration. |
| Changes of FEV1 at each time point | From baseline to 1day after treatment | Changes in series FEV1 at each time point within 12 hours after morning administration on day 1 of treatment (after first dosing) compared to baseline. |
| Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours | From 1day after treatment to 4 weeks after treatment | To evaluate the change in FEV1 peak value and FEV1 mean value within 3 hours and 12 hours after 4 weeks of treatment compared with 1 day of treatment (after first administration) |
| Change of the mean value of FEV1 | From baseline to four weeks after treatment | Compared with baseline, the mean value of FEV1 was changed within 3 hours and 12 hours after morning medication at 4 weeks of treatment. |
| Changes in Modified Medical Research Council (mMRC) Dyspnea Scale Score | Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline | mMRC Dyspnea Scale Score's total score is 0-4 points, with the higher score meaning the more severe symptoms. |
| Chronic obstructive pulmonary disease Assessment Test (CAT) | Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline | There are 8 questions in the CAT, and each question is scored 0-5 points, with the higher score meaning the more severe symptoms |
| St. George's Respiratory Questionnaire (SGRQ) | Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline | SGRQ has three parts: symptoms, abilities, and effects, and is used to comprehensively measure the physical, mental, and social status of COPD patients. |
| Basic Dyspnea Index (BDI) | Changes in BDI after 2 and 4 weeks of treatment compared with baseline. | BDI has three levels: functional impairment, magnitude of task, and magnitude of effort. Each level is rated from 0 (severe) to 4(No damage). |
| Transitional Dyspnea Index (TDI) | Changes in TDI after 2 and 4 weeks of treatment compared with baseline | TDI has three levels:changes in functional impairment, changes in magnitude of task, changes in magnitude of effort,. Scores in each area range from -3 (significant deterioration) to 0 (no change) to +3 (significant improvement). |
| Changes in Morning Valley FEV1 | From baseline to four weeks after treatment | Changes in Morning Valley FEV1 after 4 weeks of treatment compared with baseline |
Countries
China
Outcome results
None listed