Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • TQC3721 Suspension for Inhalation

Treatment groups

800 Participants
are divided into 1 treatment group