Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD (NCT07450482) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of JKN2304 Inhalation Solution in Patients With Moderate to Severe COPD
China42 participantsStarted 2025-07-22
Plain-language summary
The purpose of this Phase IIa study is to evaluate the safety, efficacy, and pharmacokinetics of JKN2304 Inhalation Solution in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study is a multicenter, randomized, double-blind, placebo-controlled, and active-controlled (open-label) trial. Participants are randomized to receive JKN2304 (2 mg once daily or 2 mg twice daily), Placebo, or Formoterol Fumarate Inhalation Solution for a treatment period of 14 days.
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
. Able to understand and comply with the trial procedures, voluntarily participate, and sign the informed consent form.
. Age between 40 and 75 years (inclusive) at the time of signing the informed consent, both males and females.
. History of exposure to COPD risk factors, such as: smoking history ≥10 pack-years (pack-years = \[number of cigarettes per day / 20\] x years smoked; use of electronic cigarettes, pipes, or cigars cannot be used to calculate pack-years), or exposure to biomass fuel for ≥10 years.
. Established diagnosis of COPD according to the GOLD 2024 guidelines prior to screening.
. History of ≥1 severe Acute Exacerbation of COPD (AECOPD) leading to hospitalization OR ≥2 moderate AECOPDs within 12 months prior to screening; OR, if ≤1 moderate AECOPD within 12 months prior to screening, then baseline mMRC score must be ≥2 and CAT score ≥10.
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
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From signing of informed consent through the safety follow-up visit (Day 21)
Trial details
NCT IDNCT07450482
SponsorJoincare Pharmaceutical Group Industry Co., Ltd
. No occurrence of AECOPD within the 4 consecutive weeks prior to screening.
. Post-bronchodilator (400 µg salbutamol) FEV1/FVC \< 0.70, and post-bronchodilator FEV1 percent predicted (ppFEV1) between 30% and 79%.
. Ability to perform acceptable and reproducible spirometry.
Exclusion criteria
. History of hypersensitivity to the investigational drug or drugs of the same class, or history of bronchospasm.
. Current diagnosis of bronchial asthma.
. Current diagnosis of other lung diseases that may impair lung function, including but not limited to: alpha-1 antitrypsin deficiency, cystic fibrosis, bronchiectasis, bronchiolitis obliterans, bronchopulmonary dysplasia, active pulmonary tuberculosis, pulmonary hypertension (except if judged by the investigator to be due to COPD), interstitial lung disease (e.g., pulmonary fibrosis), pneumothorax, etc.
. Acute lower respiratory tract infection within 4 weeks prior to or during screening.
. Hospitalization for respiratory disease within 4 weeks prior to or during screening.
. Clinically significant history of cardiovascular/cerebrovascular disease within 6 months prior to screening, such as congestive heart failure, acute coronary syndrome (including acute myocardial infarction and unstable angina), newly diagnosed atrial fibrillation, supraventricular/ventricular tachycardia, aortic aneurysm, stroke, etc.
. Poorly controlled hypertension within 6 months prior to screening (defined as failure to achieve target blood pressure despite combination therapy with ≥3 antihypertensive agents) OR confirmed systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg during screening upon repeated measurement; severe arrhythmia requiring antiarrhythmic drug therapy; sinus node dysfunction, Mobitz type II or third-degree atrioventricular block without a pacemaker.
. Narrow-angle glaucoma, bladder neck obstruction, moderate-to-severe prostatic hyperplasia, or history of acute urinary retention, judged by the investigator as a contraindication to inhaled anticholinergic drugs.