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New inhaled compound aims to ease COPD breathing woes

NCT ID NCT06748079

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental inhaled medication called TQC3721 in people with moderate to severe chronic obstructive pulmonary disease (COPD). The study aims to see how safe and tolerable the drug is, how it moves through the body, and what effects it has on lung function and symptoms. Participants will receive either the drug or a placebo, and some may also receive a combination with another inhaled medication. The results will help determine if this approach is worth further study as a potential COPD treatment.

What this could mean

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

Active substance
TQC3721 inhalation powder (a target inhibitor) given alone or with glyberlam inhalation powder, compared against placebo
What this could lead to
If safe and well-tolerated, TQC3721 could become a new inhaled treatment to help control COPD symptoms and improve quality of life.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not work as hoped or could cause side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

113 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2026

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 75 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. Age: 40-75 years old, male or female; 2. During screening, according to the Global Oceanographic Library for Discovery (GOLD)guidelines (2024), patients diagnosed with stable moderate to severe COPD should have Force Expiratory Volume in 1 second (FEV1)/ forced vital capacity (FVC)\<0.7 after inhaling bronchodilators; 40% ≤ FEV1 accounts for ≤ 80% of the expected value; 3. When screening, after inhaling salbutamol aerosol for 4 times, there is a certain reversibility in the airway: the absolute value of FEV1 improves by more than 100ml; 4.1Applicable to Part 1: Being able to adjust the current COPD treatment or for COPD patients with initial treatment, prescribed bronchodilators, including Long-acting Muscarinic Antagonists (LAMA) and/or Long-acting β2-agonist (LABA) inhaled drugs, can be discontinued during the screening period after signing the informed consent form; 4.2 Applicable to Part 2: Being able to adjust the current COPD treatment or for COPD patients with initial treatment,LAMA inhaled drugs can be used during the lead-in period after signing the informed consent form; 5.The subject is able to discontinue Short acting Beta agonists (SABA) for at least 6 hours and Short acting Anticholinergic Agents (SAMA) for at least 8 hours; 6.Smoking history ≥ 10 pack years (pack years: number of packs per day multiplied by smoking years); 7.There is no evidence to suggest active respiratory and/or cardiovascular diseases other than COPD in clinical practice (such as uncontrolled hypertension); 8.No other related lung diseases or history of thoracic surgery; 9.The subjects were able to undergo reproducible FEV1 lung function testing according to the ATS/ERS 2005 standard during screening; 10. Body mass index (BMI) is between 18-30kg/m2; 11.Participants must agree to use contraceptive methods (such as birth control pills, condoms, or intrauterine devices) with sexual partners of childbearing age during the clinical trial period (screening period to 30 days after the last dose); 12) The subject is able to use a dry powder inhaler correctly for inhalation. 13) I have fully understood this study and voluntarily participated. I have signed the 'Informed Consent Form'. Exclusion Criteria: 1 . History or current clinical instability of heart, respiratory, endocrine, metabolic, renal, liver, gastrointestinal, skin, infection, blood system, nervous system, or neurological/psychiatric disorders/abnormalities; 2. The result of the human immunodeficiency virus (HIV) antibody test is positive; The result of hepatitis B surface antigen (HBsAg) test is positive (if HBsAg is positive, Hepatitis B virus deoxyribonucleic acid (HBV-DNA) should be checked if necessary, and if HBV-DNA\<Lower Limit of Quantification (LLOQ), it does not need to be excluded); Hepatitis C virus (HCV) antibody positive and confirmed presence of HCV ribonucleic acid (RNA); Positive for Treponema pallidum antibody (TPPA); 3. Have a history of illegal drug abuse in the past; 4. Have participated in other clinical trials and received the investigational drug within 3 months prior to participating in this trial, or within 5 half lives of the investigational drug, whichever is shorter; 5. Those who have lost blood or donated more than 400 mL of blood within 2 months before the experiment; 6. Have any clear and severe history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug; 7. Drinking history (drinking 14 units of alcohol per week: 1 unit=285 ml of beer; or 25 ml of spirits; or 1 glass of wine); 8. History of malignant tumors in any organ system within the past 5 years, regardless of whether treatment has been received or not, except for local basal cell carcinoma of the skin; 9. Lower respiratory tract infection occurred within 6 weeks before screening or randomization. Upper respiratory tract infections requiring antibiotics within 6 weeks prior to screening or randomization; 10. Have a history of active tuberculosis, bronchiectasis, asthma or other non-specific lung diseases. 11\. QTcF (corrected QT interval, Fridericia formula QT \[msec\]/RR \[s\]) interval, male\>450ms, female\>470ms, or history of long QT syndrome before screening or randomization; 12. Subjects with a history of drug use in the past 2 years; 13. Subjects who are unable to comply with past medication and concomitant medication restrictions; 14. If there is a history of acute exacerbation of COPD within 3 months before screening or randomization, hospitalization or additional COPD maintenance treatment is required. Over the past three years, the average number of frequent exacerbations of COPD with moderate to severe severity has been ≥ 2 per year, or resulting in hospitalization for ≥ 2 acute exacerbations per year; 15. Oral non selective beta blockers; 16. Previously treated with TQC3721 suspension. 17. Any situation that researchers believe may pose safety risks to subjects in the trial or may interfere with the conduct of this study, or where researchers believe that subjects may not be able to complete this study or may not be able to comply with the requirements of this study (due to management or other reasons).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.