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

NCT07633314 | Not Yet Recruiting Phase 2

• 1 other identifier: TQC3927-II-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• The area under the FEV1 curve (AUC)

  The area under the curve (AUC) of the change in FEV1 from baseline (ΔFEV1) 0-12 h after the first dose of Day 14.

  Within 14 days

Secondary Outcomes (10)

• FEV1 peak

  Within 14 days

• FEV1 morning valley value

  Within 14 days

• The area under the FVC curve (AUC)

  Within 14 days

• FEV1

  Within 14 days

• CAT rating

  Within 14 days

Study Arms (3)

400 μg TQC3927 inhalation aerosol

EXPERIMENTAL

The experimental group was given 400 μg of TQC3927 inhalation powder twice daily for a total of 14 days.

Drug: TQC3927 inhalation aerosol

600 μg TQC3927 inhalation aerosol

EXPERIMENTAL

The experimental group was given 600 μg of TQC3927 inhalation powder twice daily for a total of 14 days.

Drug: TQC3927 inhalation aerosol

glycopyrronium bromide and formoterol inhaled aerosol

ACTIVE COMPARATOR

The positive control group for glycopyrronium bromide formoterol inhalation aerosol (Baiwoping® Lingchang®) was given twice daily for 14 days.

Drug: Glyceryl bromide/formoterol inhalation aerosol

Interventions

TQC3927 inhalation aerosol DRUG

TQC3927 inhaled powder: TQC3927 exhibits dual-target activity against anticholinergic antagonists and adrenergic receptor agonists (MABA).

400 μg TQC3927 inhalation aerosol; 600 μg TQC3927 inhalation aerosol

Glyceryl bromide/formoterol inhalation aerosol DRUG

Glycerone bromide formoterol inhaler: long-acting adrenergic receptor agonists (LABA) + long-acting anticholinergic antagonists (LAMA) combination therapy.

glycopyrronium bromide and formoterol inhaled aerosol

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Participants must have discontinued short-acting β2-adrenergic receptor agonist (SABA) for at least 6 hours and short-acting cholinergic receptor antagonist (SAMA) for at least 8 hours before starting any pulmonary function tests;
• Participants must be current or former smokers with a smoking history of ≥10 pack-years (pack-year: number of packs per day × number of years of smoking, such as 1 pack of 20 cigarettes per day for 10 consecutive years, or 10 cigarettes per day for 20 consecutive years); former smokers are defined as those who have quit smoking for at least 6 months prior to Visit 1. Note: Use of pipes, cigars, and e-cigarettes cannot be used to calculate packs/year;
• Trained participants are able to perform acceptable and reproducible pulmonary function tests according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 criteria;
• Participants voluntarily sign informed consent forms and have no plans for pregnancy within 90 days from the start of treatment to the last dose, and voluntarily use medically approved contraception (including with their partners);
• Trained participants are able to correctly use a pressure metered-dose inhaler (pMDI), dry powder inhaler (DPI) inhaler for drug administration;
• Participants are able to attend study visits on time and complete the visit content;

You may not qualify if:

• 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;
• Participants who have undergone lung volume reduction surgery, lobectomy/segmentectomy, or are expected to undergo lung surgery during the study period within 12 months prior to V1;
• Participants who have developed pneumonia or lower respiratory tract infections requiring antibiotic treatment within 8 weeks prior to V1 or between V1 and V3;
• Participants with clinically significant abnormalities on chest computed tomography (CT);
• Participants currently using positive pressure ventilation;
• Participants requiring long-term oxygen therapy (oxygen therapy time \> 15 minutes). 10. Individuals undergoing pulmonary rehabilitation;
• Participants who changed their smoking status (i.e., started or stopped smoking) or began a smoking cessation program within 6 weeks prior to screening;
• Individuals with unstable or life-threatening heart disease;
• Individuals using non-selective oral beta-blockers;
• Individuals with unstable or uncontrolled hypertension;
• Abnormal values in clinically significant safety laboratory tests determined by the investigator at the screening visit;
• Positive results for human immunodeficiency virus (HIV); positive results for hepatitis B surface antigen (HBsAg); positive results for hepatitis C virus (HCV) antibody and supporting documentation.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (15)

The First People' Hospital Of YuLin

Yulin, Guangxi, 537000, China

Location

Da Qing Long Nan Hospital

Daqing, Heilongjiang, 163000, China

Location

The People's Hospital of Anyang City

Anyang, Henan, 455099, China

Location

Yichang Central People's Hospital

Yichang, Hubei, 443003, China

Location

Xiangtan County People's Hospital

Xiangtan, Hunan, 411200, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

Yixing People'S Hospital

Yixing, Jiangsu, 214200, China

Location

Jiangxi Provincal People's Hospital

Nanchang, Jiangxi, 330000, China

Location

Siping Central People's Hospital

Siping, Jilin, 136099, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041099, China

Location

Chengdu Third People's Hospital

Chengdu, Sichuan, 610031, China

Location

The Fourth Central Hospital of Tianjin

Tianjin, Tianjin Municipality, 300140, China

Location

The First Affiliated Hospital of Shihezi University Shihezi

Ürümqi, Xinjiang, 832008, China

Location

The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ting Yang, Doctor

CONTACT

13651380809; dryangting@qq.com

Jintong Li, Doctor

CONTACT

15300059186; gcpljt@189.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-04

Locations

CN (15)