A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease (NCT06748079) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease
China113 participantsStarted 2024-12-03
Plain-language summary
This is a randomized, double-blind, placebo-controlled, dose escalation, multicenter study design. The purpose is to evaluate the safety, tolerability, pharmacokinetics, and pharmacokinetic characteristics of TQC3721 inhalation powder in Chronic Obstructive Pulmonary Disease(COPD) patients with single/multiple dose escalation.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 40-75 years old, male or female;
. 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;
. 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;
.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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (AE)
Timeframe: 21 days
2
Serious Adverse Events (SAE)
Timeframe: 21 days
3
Treatment-emergent adverse events (TEAEs)
Timeframe: 19 days
Trial details
NCT IDNCT06748079
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
.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'.