[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-obstructive-lung-disease-cold\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-obstructive-lung-disease-cold":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100603731","phase-2-evaluation-of-the-safety-and-efficacy-of-hsk39004-dry-powder-inhaler-and-hsk39004-inhalation-suspension-in-chinese-patients-with-chronic-obstructive-pulmonary-disease-copd-100603731",false,"NCT07140328","Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n1. During the screening visit (Visit 1), the age range is 40 to 80 years (including the threshold value), and gender is not restricted;\n2. The subjects with chronic obstructive pulmonary disease (COPD) as per the GOLD 2025 diagnostic criteria, and the symptoms before screening were consistent with COPD for at least 1 year \\[GOLD 2025 standard: the subjects have chronic respiratory symptoms such as shortness of breath, chronic cough or expectoration, and\u002For have a history of exposure to risk factors, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. During the screening visit (Visit 1):\n\n   * FEV1\u002FFVC after using bronchodilators is \\\u003C0.7;\n   * 30% of the expected value ≤ FEV1 after using bronchodilators \\\u003C 80% of the expected value; Note: Using bronchodilators refers to using 400 μg (4 puffs, 100 μg per puff, with an interval of 1 minute between each puff) salbutamol inhalation aerosol for 15 to 30 minutes after use.\n4. Clinically stable COPD in the 4 weeks prior to screening (Visit 1);\n5. During the screening period and treatment period, COPD drugs prohibited by the protocol (except for salbutamol inhalation aerosol as a rescue drug) can be discontinued;\n6. Current smokers with a smoking quantity of ≥ 10 packs per year (smoking index (pack years) = daily smoking quantity (packs) × time (years), 1 pack = 20 cigarettes), or former smokers (for example: at least 1 pack per day, for 10 years), or those with a history of exposure to other risk factors.\n\nExclusion Criteria:\n\n1. Have received treatment for COPD acute exacerbation or been hospitalized for pneumonia within 12 weeks before screening;\n2. Have had acute (viral or bacterial) upper or lower respiratory tract infections or other infectious diseases requiring antibiotic treatment within 6 weeks before screening;\n3. Have other diagnosed respiratory system diseases other than COPD, including but not limited to: α-1 antitrypsin deficiency, asthma, active tuberculosis, lung edema, cystic fibrosis, bronchiectasis, pulmonary nodular disease, or clinically significant pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, bronchiectasis (excluding asymptomatic local bronchial dilation);\n4. Have a history of or currently have severe cardiovascular diseases, including but not limited to:\n\n   * Screening period NYHA cardiac function grade III\u002FIV (according to the NYHA cardiac function grading standard, see Appendix 1);\n   * Had acute myocardial infarction, unstable angina pectoris\u002Facute coronary syndrome, percutaneous coronary intervention, coronary artery bypass grafting within 6 months before screening;\n   * Structural heart disease, such as hypertrophic cardiomyopathy, moderate to severe valvular disease;\n   * Had severe arrhythmia within 3 months before screening, such as: atrial fibrillation with a ventricular rate \\> 120 bpm, ventricular tachycardia, bradycardia (ventricular rate \\\u003C 45 bpm), second-degree II or above atrioventricular conduction block (excluding those with implanted pacemaker or defibrillator), male QTcF \\> 450 ms or female QTcF \\> 470 ms;\n   * Subjects with poor blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at the screening visit);\n5. Have type I diabetes or poorly controlled type II diabetes (fasting blood glucose ≥ 10 mmol\u002FL at screening);\n6. Have cancer (in situ cancer that has been cured for more than 5 years, skin squamous cell carcinoma and basal cell carcinoma, etc., except for subjects with suspected malignant tumors or undetermined tumors);\n7. Combine other severe unstable kidney, nervous system, endocrine diseases, thyroid diseases, urinary system, ophthalmic diseases, immune system, mental system, gastrointestinal, liver or blood system disease\u002Fabnormal history, as determined by the investigator, participation in this study may pose risks to the subjects or affect the analysis of research results;\n8. During the screening period (visit 1), the investigator determines that the laboratory tests of the subjects show clinically significant abnormalities that may pose risks to the subjects, including but not limited to the following situations:\n\n   1. The glomerular filtration rate (eGFR) calculated using the CKD-EPI formula is less than 60 mL\u002Fmin\u002F1.73m2;\n   2. Liver function: Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) are more than 2.5 times the upper limit of the normal value; Total bilirubin (TBIL) is more than 1.5 times the upper limit of the normal value.\n9. Lactose\u002Fmilk protein (dairy products) intolerance, allergy to HSK39004 or salbutamol or any known components in the administration system;\n10. Before the pulmonary function test during the screening (visit 1), any prohibited drugs in the protocol were used (see Table 4 and Table 5 of the prohibited drug list in Section 5.9.3);\n11. Within 12 months before screening, received lobectomy or lung volume reduction surgery;\n12. Had major surgery (requiring general anesthesia) within 6 weeks before screening, not fully recovered at the time of screening, or planned to undergo surgery before the end of the study;\n13. Patients determined by the investigator to require oxygen therapy;\n14. Have clinically significant apnea that requires the use of a continuous airway positive pressure ventilation (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device;","ALL","40 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.",[27],"Chronic Obstructive Lung Disease (COLD)","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-09","ACTUAL",{"date":34,"type":32},"2025-04-24",{"date":36,"type":21},"2026-08",{"name":38,"class":39},"Haisco Pharmaceutical Group Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100625636","phase-2-long-term-safety-and-efficacy-of-hsk39004-dry-powder-inhaler-in-copd-100625636","NCT07425210","Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD","A Multicenter, Single-Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)","Key Inclusion Criteria:\n\n1. Aged 40 to 80 years (inclusive) at the time of screening visit (Visit 1), male or female;\n2. Subjects diagnosed with chronic obstructive pulmonary disease (COPD) in accordance with the GOLD 2026 diagnostic criteria prior to screening \\[GOLD 2026 criteria: presence of chronic respiratory symptoms such as dyspnea, chronic cough or sputum production, and\u002For a history of risk factor exposure, and the pulmonary function test results show: the forced expiratory volume in one second (FEV1) after using bronchodilators \u002F forced vital capacity (FVC) \\\u003C0.7\\];\n3. At screening visit (Visit 1):\n\n   * Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7; and\n   * Post-bronchodilator FEV1 ≥ 30% and \\\u003C 80% of predicted value;\n4. Modified Medical Research Council (mMRC) dyspnea scale score ≥ 2 at screening;\n\nKey Exclusion Criteria:\n\n1. Subjects with unresolved lower respiratory tract infection occurring within 6 weeks prior to screening (Visit 1) and\u002For before enrollment;\n2. Severe or uncontrolled cardiovascular disease or history, including but not limited to: New York Heart Association (NYHA) functional class III\u002FIV at screening; acute myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening; clinically significant arrhythmia requiring intervention or marked QTcF prolongation (male \\>450 ms, female \\>470 ms) within 3 months prior to screening; or unstable or uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg) at screening;\n3. History of malignancy (except for carcinoma in situ, cutaneous squamous cell carcinoma, and basal cell carcinoma cured for more than 5 years), suspected malignancy, or undetermined neoplasm;\n4. Concurrent severe, uncontrolled renal, neurological, endocrine, thyroid, urological, ophthalmic, immunological, psychiatric, gastrointestinal, hepatic, or hematological diseases\u002Fabnormalities that, in the investigator's judgment, may pose a safety risk to the subject or confound study outcome analysis;\n5. Known hypersensitivity to HSK39004 inhalation powder, salbutamol, or any component of the drug delivery system;\n6. Use of any protocol-prohibited medication prior to spirometry at screening (Visit 1);\n7. History of lung lobectomy or lung volume reduction surgery within 12 months prior to screening;\n8. Major surgery (requiring general anesthesia) within 6 weeks prior to screening with incomplete recovery, or planned surgery before study completion;\n9. Subjects determined by the investigator to require oxygen therapy;\n10. Clinically significant sleep apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV);",{"count":49,"type":21},300,[24],"This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive pulmonary disease (COPD), including both newly enrolled and those who have completed prior participation in the HSK39004-201, HSK39004-T1-201, or HSK39004-T1-202 studies as a long-term extension.",[27],"NOT_YET_RECRUITING","2026-02-23",{"date":56,"type":32},"2026-02-25",{"date":58,"type":21},"2026-03",{"date":60,"type":21},"2027-08",{"name":38,"class":39},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":70,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":40},"100585057","reforat-a-community-social-and-healthcare-program-for-patients-with-cardiorespiratory-conditions-upon-hospital-discharge-100585057","NCT06897410","Reforça't: A Community, Social, and Healthcare Program for Patients With Cardiorespiratory Conditions Upon Hospital Discharge","Reforça't: A Randomized Community Clinical Trial With a Social and Healthcare Approach to Improve Functional Outcomes in Patients With Chronic Cardiac, Respiratory, or Mixed Conditions After Hospital Discharge","R't","Inclusion Criteria:\n\n* Users admitted to the Polivalent Observation Units, Internal Medicine, or Hospital at home.\n* Individuals aged 65 years or older.\n* Hospital admission due to decompensation of a cardiac, respiratory, or mixed condition.\n* Place of residence within the health coverage area of Sant Jaume de Calella Hospital - Corporació de Salut del Maresme i la Selva.\n* Willingness to participate in the study as gathered by the signing of an informed consent document\n\nExclusion Criteria:\n\n* Users institutionalized in a nursing home\n* Users already enrolled in home care programs\n* Users in the Advanced Chronic Care Model program with a limited life prognosis\n* Users on the waiting list for organ transplantation\n* Users with language barriers\n* Users with a GDS (Global Deterioration Scale) score of 5 or higher\n* Users who have already been included in the Reforça't program","65 Years",{"count":72,"type":21},200,[74],"NA","The goal of this randomized clinical trial is to determine whether an interdisciplinary, community-based intervention can reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions following hospital discharge.\n\nThe main questions it aims to answer are:\n\nCan the Reforça't program reduce 30-day hospital readmission rates to 25% compared to standard care? Does participation in Reforça't improve functional outcomes, medication adherence, quality of life, and mortality rates in this patient population?\n\nResearchers will compare patients enrolled in Reforça't (intervention group) with those receiving standard care (control group) to determine whether the program leads to lower readmission rates, improved health outcomes, and higher cost-effectiveness.\n\nParticipants will:\n\nUndergo a pre- and post-intervention assessment (30 days post-discharge). Receive comprehensive, interdisciplinary care integrating medical, social, and rehabilitation services.\n\nBe monitored for 12 months to assess readmissions, survival, nursing home admissions, and overall well-being.",[27,77],"Heart Failure",[79,80,77,81,82],"Patient Readmission","COLD","Frail elderly","Multidisciplinary care team","2025-05-26",{"date":85,"type":32},"2025-05-30",{"date":87,"type":32},"2025-01-13",{"date":89,"type":21},"2026-06-30",{"name":91,"class":92},"Corporació de Salut del Maresme i la Selva","OTHER"]