A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive Pulmonary Disease

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Sign an informed consent form before the trial to fully understand the purpose, procedure, and possible adverse reactions;

Age: 40 years ≤ age ≤ 75 years (calculated from the date of signing the informed consent form), gender not limited;

Participants' body mass index (BMI) is within the range of 18~30 kg/m2 (including the borderline), and their weight is ≥45kg;

Diagnosed with Chronic Obstructive Lung Disease (COPD) according to the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, and symptoms consistent with COPD for at least 1 year before the screening visit (V1);

Disqualifiers

Participants currently diagnosed with asthma (including asthma with COPD) or with a history of asthma, based on the investigator's judgment;

Participants with a current life-threatening COPD history;

Participants with concurrent active or clinically significant respiratory illnesses that significantly impact the study;

Participants with serious illnesses other than COPD, or abnormalities in laboratory tests, electrocardiograms, medical history, or physical examinations;

Trial design

Treatments tested in this trial

  • TQC3927 inhalation aerosol
  • Glyceryl bromide/formoterol inhalation aerosol

Treatment groups

90 Participants
are divided into 3 treatment groups