[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640943":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":31,"eligibilityCriteria":32,"healthyVolunteers":27,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":20,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":45,"overallStatus":46,"whyStopped":20,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":20},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Budesonide\u002FGlycopyrronium Bromide\u002FFormoterol","EXPERIMENTAL","budesonide\u002Fglycopyrronium bromide\u002Fformoterol inhalation aerosol",[13],"Drug: Budesonide\u002Fglycopyrronium bromide\u002Fformoterol inhalation aerosol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Budesonide\u002Fglycopyrronium bromide\u002Fformoterol inhalation aerosol","Budesonide\u002Fglycopyrronium\u002Fformoterol inhalation aerosol delivers budesonide (160 μg), glycopyrronium (7.2 μg), and formoterol (4.8 μg) per actuation. It is administered as two inhalations twice daily (two in the morning and two in the evening), approximately 12 hours apart, via a pressurized metered-dose inhaler (pMDI). Subjects are required to receive standardized training on inhalation technique to ensure proper technique.",[9],null,{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","zhuansyx","Professor","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":37,"type":38},23,"ESTIMATED","INTERVENTIONAL",[41],"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.",[44],"Preserved Ratio Impaired Spirometry (PRISM)",[44],"NOT_YET_RECRUITING","2026-05-13",{"date":49,"type":50},"2026-05-19","ACTUAL",{"date":52,"type":38},"2026-06-01",{"date":54,"type":38},"2028-02-29",{"name":5,"class":6}]