Evaluation of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

NCT07147946 Phase 3 NOT_YET_RECRUITING

To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	666
Start date	2025-09
Completion	2027-06

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

• TQC3721 Suspension for inhalation
• Placebo of TQC3721 Suspension for Inhalation

Primary outcomes

• 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.

Countries

China