[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preserved-ratio-impaired-spirometry-prism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preserved-ratio-impaired-spirometry-prism":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,75,102,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100640943","an-exploratory-study-on-triple-inhaler-therapy-in-patients-with-early-lung-function-impairment-100640943",false,"NCT07595796","An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment","Efficacy Evaluation of Budesonide\u002FGlycopyrronium Bromide\u002FFormoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial","BGF-PRISm","Inclusion Criteria:\n\n1. Age 40-75 years;\n2. Smoking history ≥10 pack-years;\n3. Pulmonary function test showing 0.7 ≤ FEV1\u002FFVC \\\u003C 0.8 and FEV1 \\\u003C 80% predicted;\n4. Presence of at least one chronic respiratory symptom (e.g., cough, sputum, dyspnea) lasting ≥3 months;\n5. Voluntarily sign a written informed consent form, be able to understand the study objectives, and comply with follow-up requirements;\n6. The investigator assesses that the subject is able to complete the 12-week treatment and follow-up and has good medication adherence.\n\nExclusion Criteria:\n\n1. Concomitant Respiratory Diseases: (1) Diagnosed asthma, bronchiectasis, interstitial lung disease, active tuberculosis, or lung cancer. (2) Meeting the diagnostic criteria for chronic obstructive pulmonary disease (COPD) (post-bronchodilator FEV1\u002FFVC \\\u003C 0.7). (3) Acute respiratory infection or exacerbation within 4 weeks prior to enrollment.\n2. Cardiovascular Disease Risks: (1) Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg). (2) Myocardial infarction, unstable angina, malignant arrhythmia, or cardiac insufficiency (NYHA class ≥III) within the past 6 months. (3) Long-term use of beta-blockers or antiarrhythmic drugs.\n3. Drug-Related Contraindications: (1) Allergy to budesonide, glycopyrronium bromide, formoterol, or excipients of the inhalation aerosol. (2) Use of long-acting bronchodilators (LABA, LAMA), inhaled corticosteroids, or immunosuppressants within 4 weeks prior to enrollment.\n4. Other Systemic Diseases: (1) Severe hepatic or renal insufficiency (ALT\u002FAST \\> 3 times the upper limit of normal, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²). (2) Uncontrolled diabetes (HbA1c \\> 9%) or hyperthyroidism.\n5. Special Populations and Compliance Issues: (1) Pregnant or lactating women, or women planning pregnancy without using effective contraception. (2) History of substance abuse, psychiatric disorders, or cognitive impairment that may affect study compliance. (3) The investigator deems the subject unsuitable for participation for other reasons (e.g., life expectancy \\\u003C 1 year, inability to complete follow-up).","ALL","40 Years","75 Years",{"count":21,"type":22},23,"ESTIMATED","INTERVENTIONAL",[25],"NA","Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)\u002Fforced vital capacity (FVC) ratio but an FEV1 below 80% of the predicted value. It has a population prevalence of approximately 10% and is associated with marked symptoms, a high risk of acute exacerbations, and increased mortality. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines PRISm as a pre-chronic obstructive pulmonary disease (COPD) state, and 20%-30% of patients with PRISm will progress to COPD. Currently, no evidence-based therapy exists for PRISm; management is mainly symptomatic relief, and there is an urgent need for evidence-based support. This single-arm clinical trial preliminarily evaluates the efficacy and safety of budesonide\u002Fglycopyrronium\u002Fformoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1\u002FFVC ratio ≥0.7 and \\\u003C0.8 are enrolled and treated with budesonide\u002Fglycopyrronium\u002Fformoterol inhalation therapy for 12 weeks. The primary endpoint is the change from baseline in FEV1; secondary endpoints include symptom score (COPD Assessment Test, CAT) and quality of life (St George's Respiratory Questionnaire, SGRQ); safety is assessed by recording adverse events (e.g., cardiovascular events); and exploratory analyses examine the association between biomarkers (e.g., peripheral blood eosinophil count, serum IgE level) and treatment efficacy. The study aims to preliminarily explore the efficacy and safety of budesonide\u002Fglycopyrronium\u002Fformoterol inhaler therapy for PRISm. Early intervention may delay the progression from PRISm to COPD, reduce the burden of chronic respiratory disease, and have important clinical translational value and public health significance.",[28],"Preserved Ratio Impaired Spirometry (PRISM)",[28],"NOT_YET_RECRUITING","2026-05-13",{"date":33,"type":34},"2026-05-19","ACTUAL",{"date":36,"type":22},"2026-06-01",{"date":38,"type":22},"2028-02-29",{"name":40,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100568561","comparison-of-clinical-status-of-individuals-with-copd-and-preserved-ratio-impaired-spirometry-100568561","NCT06682832","Comparison of Clinical Status of Individuals With COPD and Preserved Ratio Impaired Spirometry","Comparison of Exercise Capacity, Muscle Strength and Oxygenation, Arterial Stiffness, Physical Activity and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease and Impaired Spirometry With Preserved Ratio","Inclusion Criteria:\n\nPRISm group inclusion criteria;\n\n* Being \\>40 years old,\n* Being diagnosed with PRISm,\n* Volunteering to participate in the study,\n* Not having any orthopaedic or neurological problems that may prevent participation in the measurements,\n* Co-operation with measurements\n\nInclusion criteria for the COPD group;\n\n* Being \\>40 years old,\n* Being diagnosed with COPD,\n* To be clinically stable,\n* Volunteering to participate in the study.\n\nInclusion criteria for healthy individuals;\n\n* Being \\>40 years old,\n* Volunteering to participate in the study,\n* No known chronic health problems,\n* To be able to co-operate with the measurements.\n\nExclusion Criteria:\n\nPRISm group exclusion criteria;\n\n* Being diagnosed with COPD,\n* Severe orthopaedic, neurological and cardiac diseases\n* Not volunteering to participate in the study\n\nExclusion criteria for COPD group;\n\n* Severe orthopaedic, neurological and cardiac diseases,\n* Being in COPD exacerbation period,\n* Not volunteering to participate in the study.\n\nHealthy individuals exclusion criteria;\n\n* Having a known chronic disease,\n* Not volunteering to participate in the study",true,{"count":51,"type":22},54,"1 Day","OBSERVATIONAL","Despite the globally varying high prevalence rate of the PRISm phenotype, there are no guidelines for its diagnostic evaluation and management. Further studies are needed on appropriate approaches for individuals with PRISm to improve respiratory symptoms and prognosis. As research continues to evolve, PRISm needs to be recognized as a critical component of pulmonary assessments and at-risk individuals need to be provided with appropriate treatment and follow-up to prevent progression to COPD. There are no studies in the literature comparing PRISm, respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in COPD and healthy individuals. The aim of this study was to compare respiratory muscle strength, peripheral muscle strength and oxygenation, arterial stiffness, physical activity level and sleep level in PRISm, COPD and healthy subjects.",[56,28],"Chronic Obstructive Pulmonary Disease (COPD)",[58,59,60,61,62,63],"COPD","PRISm","exercise capacity","muscle strength","arterial stiffness","physical activity","RECRUITING","2026-03-27",{"date":67,"type":34},"2026-03-31",{"date":69,"type":34},"2025-09-18",{"date":71,"type":22},"2026-09",{"name":73,"class":41},"Hacettepe University",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":74},"100622731","role-of-exercise-in-prism-and-subsequent-development-of-copd-100622731","NCT07387432","Role of Exercise in PRISm and Subsequent Development of COPD","Role of Exercise in Functional Capacity of Smokers and Subsequent Development of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Age 18 or above\n* Smoker\u002F ex-smoker\n* Spirometry shows PRISm, with FEV1\u002FFVC \\>= 0.7 and FEV1 \\\u003C80% predicted\n* Ambulatory to walk\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Age below 18\n* Non-smoker\n* Spirometry does not show PRISm\u002F unable to perform spirometry\n* Requires assistance for walking\n* Unable to give informed consent","18 Years",{"count":84,"type":22},90,[25],"Preserved Ratio Impaired Spirometry (PRISm) describes individual with spirometry findings of forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted.\n\nWhile the spirometry findings of individuals with PRISm can be transited into obstructive pattern, remains at PRISm or become normal spirometry, limited evidence is on the role of exercise in the course of PRISm. This study aims to investigate the role of exercise, namely exercise with telehealth and walking exercise, together with smoking cessation advice, would alter the clinical course of PRISm.",[28],[89,59,90,91,92],"Preserved ratio impaired spirometry","exercise with telehealth","walking exercise","smoking cessation","2026-03-04",{"date":95,"type":34},"2026-03-06",{"date":97,"type":34},"2025-07-14",{"date":99,"type":22},"2028-01",{"name":101,"class":41},"The University of Hong Kong",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100603310","mitigating-chronic-respiratory-disease-through-the-lens-of-multimorbidity-mares3-100603310","NCT07134855","Mitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3)","Evaluating Care Pathways for Chronic Respiratory Diseases in Brazil","Inclusion Criteria:\n\nParticipated in MARES1 and MARES2, which recruited people with non-communicable diseases attending primary healthcare services in Brazil, identified as being at high-risk for, or confirmed as having chronic respiratory diseases.\n\nExclusion Criteria:\n\n* No consent to take part in MARES3.","30 Years",{"count":111,"type":22},473,"The investigators aim to investigate how individuals attending primary healthcare (PHC) services in Brazil for treatment of non-communicable diseases (NCDs), identified there as having abnormal spirometry or as being at high risk for lung health problems (such as asthma and chronic obstructive pulmonary disease-COPD, collectively referred to as chronic respiratory disease (CRDs)) using the COLA-6 questionnaire, are able to access diagnostic testing and treatment.\n\nThe investigators will re-assess people diagnosed with abnormal spirometry in the MARES1 study (NCT07050823) or identified as being at high-risk for CRDs in the MARES2 study (NCT07093021). The estimated sample size is 309 from MARES1 and 164 from MARES2 for a total sample size of 473.\n\nQualitative interviews will be conducted with a diverse subsample of 30 participants to explore their experience accessing CRD diagnosis and treatment, including barriers and facilitators, while all participants will undergo basic data collection and spirometry.",[56,114,28],"Asthma",[116,117,118],"chronic obstructive pulmonary disease","asthma","multi-morbidity","2025-08-14",{"date":121,"type":34},"2025-08-21",{"date":123,"type":22},"2025-09-01",{"date":125,"type":22},"2028-07-31",{"name":127,"class":41},"University College, London",2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":74},"100560481","respiratory-disease-cohort-studies-of-chinese-medicine-for-copdresearch-copd-100560481","NCT06577701","Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)","Respiratory Disease Cohort Studies of Chinese Medicine for Chronic Obstructive Pulmoriary Disease (RESEARCH-COPD)","Inclusion Criteria:\n\n* Meets diagnostic criteria for chronic obstructive pulmonary disease (COPD) or preserved ratio impaired spirometry (PRISm).\n* Age ranges from 18 years to 80 years.\n* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.\n\nExclusion Criteria:\n\n* Patients with delirium, dementia, various mental illnesses.\n* Pregnant and planned pregnant or lactating women.\n* Patients with other serious systemic diseases.\n* Patients who, in the opinion of the investigator, are not suitable for participation in this study.","80 Years",{"count":138,"type":22},10000,"This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established.",[141,28],"Chronic Obstructive Pulmoriary Disease (COPD)",[141,28,143,144,145,146],"Complication (medicine)","Traditional Chinese Medicine","Registration","Cohort study","2024-09-03",{"date":149,"type":34},"2024-09-19",{"date":151,"type":22},"2024-10-01",{"date":153,"type":22},"2027-10-30",{"name":155,"class":41},"Henan University of Traditional Chinese Medicine"]