Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Interventions
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor
DRUGPlacebo of TQC3721 Suspension for Inhalation
Placebo without 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
1. Sign an informed consent form before screening and fully understand the trial content, process, and potential adverse reactions. 2. Comply with the experimental schedule and be able to use the nebulizer inhaler correctly. 3. The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible. 4. The subjects have no pregnancy plans and voluntarily take effective contraceptive measures for at least one month from screening to the last use of the study drug. 5. Patients with a clear clinical history and related symptoms of COPD before screening. 6. Capable of conducting acceptable and reproducible lung function tests. 7. COPD clinical stability (no moderate to severe COPD acute exacerbation) within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit. 8. Smoking history ≥ 10 pack years.
Exclusion criteria
1. A history of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation. 2. COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit). 3. Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia. 4. Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit). 5. Simultaneously suffering from other respiratory diseases. 6. Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD. 7. Previous lung resection or lung reduction surgery. 11.Previously received TQC3721 treatment. 12.Patients who received immunosuppressant therapy within 4 weeks prior to the screening period 13.In the investigator's assessment, patients are unable to discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of the study; 14.Patients with a history of uncontrolled current diseases that the investigator judges to be clinically significant; 15.A history or current evidence of clinically significant cardiovascular or cerebrovascular diseases; 16.A history of malignant tumors (cured or uncured) in any organ or system within the past 5 years; 17.Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD; 18.Patients requiring long-term oxygen therapy; 19.Female subjects who are currently pregnant, breastfeeding, or planning to become pregnant during the study period after enrollment; 20.Having participated in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit; 21.Other conditions deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1) | Baseline to 12 weeks after treatment | Change from baseline in mean FEV1 AUC over 0-12 hours after 12 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in trough FEV1 values | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Changes from baseline in morning trough FEV1 at Weeks 6, 12, and 24 of treatment. |
| Average FEV1 AUC 0-4h | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Change from baseline in the average FEV1 AUC 0-4h within 4 hours after morning dosing at 6, 12, and 24 weeks of treatment. |
| St. George's Respiratory Questionnaire | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Changes in St. George's Respiratory Questionnaire (SGRQ) total scores from baseline at 6, 12, and 24 weeks of treatment. |
| Chronic Obstructive Pulmonary Disease Assessment Test | At 6 weeks, 12 weeks, and 24 weeks of treatment | Self-assessment for Patients with COPD：Numbers 0 to 5 indicate the severity (with 0 being the mildest and 5 being the most severe). |
| Average FEV1 AUC (6-12h) | Baseline to 12 weeks after treatment | Change from baseline in mean FEV₁ AUC (6-12 h) at Week 12 following dosing. |
| Annual rate of acute exacerbation of COPD | Baseline to 24 weeks after treatment | The annualized rate of acute exacerbation of moderate/severe COPD after 24 weeks of treatment. |
| Time of first acute exacerbation of moderate/severe COPD | Baseline to 24 weeks after treatment | The time of the first acute exacerbation of moderate/severe COPD within 24 weeks of treatment. |
| Changes in peak FEV1 value | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Changes from baseline in peak FEV1 within 4 hours after morning dosing at Weeks 6, 12, and 24 of treatment. |
| Assessment of respiratory symptoms in COPD | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Change from baseline in weekly mean Evaluating Respiratory Symptoms in COPD total score |
| Transition Dyspnea Index (TDI) score | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Change in Transition Dyspnea Index (TDI) score relative to Baseline Dyspnea Index (BDI) score |
| Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment | Change in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score from baseline |
| Change from baseline in rescue medication use | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment. | Changes from baseline in rescue medication use during treatment at Weeks 6, 12, and 24 versus the placebo group |
| Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24 | At Week 12 and Week 24 | IL-6, IL-8, and C-reactive protein (CRP) at Week 12 and Week 24. The elevated serum C-reactive protein (CRP) levels in patients with chronic obstructive pulmonary disease (COPD) are primarily associated with pulmonary inflammatory responses. |
| Plasma drug peak concentration | Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose | Perform Pharmacokinetics (PK) analysis of TQC3721 blood drug concentration data at baseline, week 6, and week 12 to evaluate the PK characteristics of TQC3721 in COPD patients. |
| Adverse event (AE) | D-28 to within 25 weeks of treatment | The number of participants with AEs, serious dverse event (SAEs), drug-related AEs, and abnormal lab results. |
Countries
China
Contacts
Primary ContactWeimin Li, Doctor
Outcome results
None listed