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 range40 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Able to understand and comply with the trial procedures, voluntarily participate, and sign the informed consent form.
ā. Age between 40 and 75 years (inclusive) at the time of signing the informed consent, both males and females.
ā. History of exposure to COPD risk factors, such as: smoking history ā„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 ā„10 years.
ā. Established diagnosis of COPD according to the GOLD 2024 guidelines prior to screening.
ā. History of ā„1 severe Acute Exacerbation of COPD (AECOPD) leading to hospitalization OR ā„2 moderate AECOPDs within 12 months prior to screening; OR, if ā¤1 moderate AECOPD within 12 months prior to screening, then baseline mMRC score must be ā„2 and CAT score ā„10.
ā. No occurrence of AECOPD within the 4 consecutive weeks prior to screening.
ā. Post-bronchodilator (400 Āµg salbutamol) FEV1/FVC \< 0.70, and post-bronchodilator FEV1 percent predicted (ppFEV1) between 30% and 79%.
ā. Ability to perform acceptable and reproducible spirometry.
Exclusion criteria
ā. History of hypersensitivity to the investigational drug or drugs of the same class, or history of bronchospasm.
ā. Current diagnosis of bronchial asthma.
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
. 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.
ā. Acute lower respiratory tract infection within 4 weeks prior to or during screening.
ā. Hospitalization for respiratory disease within 4 weeks prior to or during screening.
ā. 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.
ā. Poorly controlled hypertension within 6 months prior to screening (defined as failure to achieve target blood pressure despite combination therapy with ā„3 antihypertensive agents) OR confirmed systolic BP ā„160 mmHg and/or diastolic BP ā„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.
ā. 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.