A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study ID
- NCT07633314
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- TQC3927 inhalation aerosol — DRUGTQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
- Glyceryl bromide/formoterol inhalation aerosol — DRUGGlycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.
Study Details
This is a multicenter, randomized, open-label, positive-drug controlled study designed to evaluate the preliminary efficacy and safety of different doses of TQC3927 inhaled powder for short-term treatment of patients with chronic obstructive pulmonary disease, and to observe the symptoms and pharmacokinetic (PK) characteristics of participants.
Key Dates
- First listed
- Jun 8, 2026
- Start date
- Jul 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 400 μg TQC3927 inhalation aerosolThe experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days.
- Experimental: 600 μg TQC3927 inhalation aerosolThe experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days.
- Active Comparator: glycopyrronium bromide and formoterol inhaled aerosolThe positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days.
Primary Outcome Measure
The area under the FEV1 curve (AUC) [ Time Frame: Within 14 days ]
Central Contacts
- Ting Yang, Doctor13651380809
- Jintong Li, Doctor15300059186
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