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New inhaled drug aims to ease COPD breathing

NCT ID NCT07147946

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This Phase 3 trial tests an inhaled drug called TQC3721 in 666 people with moderate-to-severe COPD. The drug works by reducing inflammation and opening airways. Participants will inhale the drug or a placebo daily for up to 24 weeks to see if it improves lung function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TQC3721 suspension for inhalation (a PDE3/4 inhibitor)
What this could lead to
If successful, this could provide a new inhaled treatment option to help control COPD symptoms and improve lung function.
What could go wrong
This is a Phase 3 trial, but results may not show significant benefit over placebo. Side effects from the drug are possible, and it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 666 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sign an informed consent form before screening and fully understand the trial content, process, and potential adverse reactions. 2. Comply with the experimental schedule and be able to use the nebulizer inhaler correctly. 3. The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible. 4. The subjects have no pregnancy plans and voluntarily take effective contraceptive measures for at least one month from screening to the last use of the study drug. 5. Patients with a clear clinical history and related symptoms of COPD before screening. 6. Capable of conducting acceptable and reproducible lung function tests. 7. COPD clinical stability (no moderate to severe COPD acute exacerbation) within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit. 8. Smoking history ≥ 10 pack years. Exclusion Criteria: 1. A history of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation. 2. COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit). 3. Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia. 4. Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit). 5. Simultaneously suffering from other respiratory diseases. 6. Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD. 7. Previous lung resection or lung reduction surgery. 11.Previously received TQC3721 treatment. 12.Patients who received immunosuppressant therapy within 4 weeks prior to the screening period 13.In the investigator's assessment, patients are unable to discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of the study; 14.Patients with a history of uncontrolled current diseases that the investigator judges to be clinically significant; 15.A history or current evidence of clinically significant cardiovascular or cerebrovascular diseases; 16.A history of malignant tumors (cured or uncured) in any organ or system within the past 5 years; 17.Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD; 18.Patients requiring long-term oxygen therapy; 19.Female subjects who are currently pregnant, breastfeeding, or planning to become pregnant during the study period after enrollment; 20.Having participated in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit; 21.Other conditions deemed unsuitable for participation in the study by the investigator.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    76 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029, China

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000, China

  • Baoji Central Hospital

    Baoji, Shanxi, 721008, China

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 14000, China

  • Binzhou People's Hospital

    Binzhou, Shandong, 256610, China

  • Bozhou People's Hospital

    Bozhou, Anhui, 236805, China

  • Cangzhou Hospital of Integrated TCM- WM·HEBEI

    Cangzhou, Hebei, 61013, China

  • Central Hospital of Dalian University of Technology

    Dalian, Liaoning, 116000, China

  • Changzhi People's Hospital

    Changzhi, Shanxi, 46000, China

  • Chaohu Hospital of Anhui Medical University

    Hefei, Anhui, 238000, China

  • Chengdu Second People's Hospital

    Chengdu, Sichuan, 610017, China

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 24000, China

  • Chizhou People's Hospital

    Chizhou, Anhui, 247000, China

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000, China

  • Daqing Longnan Hospital

    Daqing, Heilongjiang, 163000, China

  • Dongyang People's Hospital

    Jinhua, Zhejiang, 322100, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

  • Fuling Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality, 408099, China

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730099, China

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550000, China

  • Hebei Medical University Third Hospital

    Shijiazhuang, Hebei, 65799, China

  • Hebei PetroChina Central Hospital

    Langfang, Hebei, 65000, China

  • Heze Municipal Hospital

    Heze, Shandong, 274031, China

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516000, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410001, China

  • Inner Mongolia Medical University Affiliated Hospital

    Hohhot, Inner Mongolia, 10000, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Jiangyin Hospital of Traditional Chinese Medicine

    Wuxi, Jiangsu, 214400, China

  • Jiaozuo Second People's Hospital

    Jiaozuo, Henan, 454001, China

  • Jinhua municipal central hospital

    Jinhua, Zhejiang, 321000, China

  • Jiujiang First People's Hospital

    Jiujiang, Jiangxi, 332000, China

  • Longgang District People's Hospital of Shenzhen

    Shenzhen, Guangdong, 518000, China

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000, China

  • Mianyang Hospital of Traditional Chinese Medicine

    Mianyang, Sichuan, 621000, China

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 21100, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518000, China

  • Peolpe's Hospital Of Chongqing Banan District

    Chongqing, Chongqing Municipality, 400054, China

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001, China

  • Qinghai Provincial People's Hospital

    Xining, Qinghai, 810007, China

  • Qiqihar First Hospital

    Qiqihar, Heilongjiang, 161005, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200023, China

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang, 312000, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110021, China

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu, 225001, China

  • Suining Central Hospital

    Suining, Sichuan, 629099, China

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318000, China

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan, 425002, China

  • The Eighth Affiliated Hospital of Southern Medical University（The First people's Hospital of Shunde ）

    Foshan, Guangdong, 528300, China

  • The Fifth People's Hospital of Wuxi

    Wuxi, Jiangsu, 214001, China

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610000, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010, China

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570102, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315000, China

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang, 832008, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

  • The First Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 66000, China

  • The First People's Hospital of Shangqiu

    Shangqiu, Henan, 476100, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang, 314000, China

  • The first hospital of Jilin University

    Changchun, Jilin, 130000, China

  • Tianjin 4th Center Hospital

    Tianjin, Tianjin Municipality, 300140, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Weifang NO.2 People's Hospital

    Weifang, Shandong, 261041, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044, China

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710100, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410028, China

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009, China

  • Yan'an University Xianyang Hospital

    Xianyang, Shaanxi, 712000, China

  • Yangquan coal Industry(Group) General Hospital

    Yangquan, Shanxi, 45000, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099, China

  • Yichang Central People's Hospital

    Yichang, Hubei, 443003, China

  • Yixing People's Hospital

    Yixing, Jiangsu, 225000, China

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000, China

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