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
Suspended

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQC3927 inhalation aerosol — DRUG
    TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).
  • Glyceryl bromide/formoterol inhalation aerosol — DRUG
    Glycerone 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
Dec 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 aerosol
    The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days.
  • Experimental: 600 μg TQC3927 inhalation aerosol
    The 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 aerosol
    The 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 ]

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