To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease
Subjects who have completed the TQC3721-III-01 clinical trial, demonstrated good medication compliance during the 24-week treatment period as required by the protocol (with no major protocol deviations related to medication compliance), and experienced no treatment-related SAEs.
Sign the informed consent form and fully understand the trial content, procedures, and potential adverse reactions.
Willing and able to comply with the trial arrangements and to use the nebulizer correctly.
Subjects have no pregnancy plans from screening until at least 1 month after the last dose of the investigational drug and voluntarily adopt effective contraception measures.
History of life-threatening chronic obstructive pulmonary disease (COPD) (e.g., prior intensive care unit admission or requiring intubation).
Presence of other clinically significant respiratory diseases, such as alpha-1 antitrypsin deficiency, active pulmonary infection, bronchiectasis, interstitial lung disease, pulmonary arterial hypertension, or asthma.
Any other systemic disease deemed by the investigator to be clinically significant and not adequately controlled at present.
Poorly controlled hypertension despite medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
Single group
TQC3721 Suspension for Inhalation
DrugTQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Number of subjects with laboratory abnormalities
Number of subjects with laboratory tests showing abnormal results
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
Change in FEV₁ from baseline (pulmonary function at screening) at 12 weeks of treatment
Annualized rate of moderate or severe COPD acute exacerbations
Annualized rate of moderate or severe Obstructive Chronic Pulmonary Disease (COPD) acute exacerbations over 48 weeks of treatment (compared according to the treatment groups in the TQC3721-III-01 study).
On-treatment time to first moderate or severe exacerbation
Time to first moderate or severe COPD exacerbation over the 48-week treatment period (To be compared according to the randomized treatment groups assigned in the TQC3721-III-01 study).
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
Analysis of change from baseline in trough FEV₁ at weeks 32, 40, and 48 of treatment (Baseline is defined as the corresponding value from the TQC3721-III-01 study; comparisons will be performed according to the randomized treatment groups assigned in that study).
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