An interventional study of Budesonide/glycopyrronium bromide/formoterol inhalation aerosol in Preserved Ratio Impaired Spirometry (PRISM), sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)/forced 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/glycopyrronium/formoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1/FVC ratio ≥0.7 and \<0.8 are enrolled and treated with budesonide/glycopyrronium/formoterol 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/glycopyrronium/formoterol 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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Drug: Budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Budesonide/glycopyrronium/formoterol 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.
Trough forced expiratory volume in the first second (trough FEV1)
Pulmonary function tests will be conducted using standardized spirometry (in accordance with ATS/ERS guidelines) at 12 hours post-dose (trough state).
Time frame: Baseline, Week 6, and Week 12
Saint George's Respiratory Questionnaire (SGRQ) Score
The standardized SGRQ (Chinese version) will be self-administered by the subjects.
Time frame: Baseline, Week 6, and Week 12
COPD Assessment Test (CAT) Score
The standardized CAT questionnaire (Chinese version) will be self-administered by the subjects.
Time frame: Baseline, Week 6, and Week 12
Adverse events (AEs) and serious adverse events (SAEs)
All AE/SAE occurrences and types during the treatment period will be recorded. Grading will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Causality and severity will be assessed by the investigator.
Time frame: Baseline, Week 6, and Week 12
The association between biomarkers (such as peripheral blood eosinophil count and serum IgE level) and treatment efficacy
1. Stratify by baseline peripheral blood eosinophil (EOS) count: (i) EOS \<100/μL (ii) EOS ≥100 to \<300/μL (iii) EOS ≥300/μL Assess the improvement in trough FEV1 according to EOS count level. 2. Stratify by serum IgE level: (i) IgE \> upper limit of normal (ULN) (ii) IgE normal Assess the improvement in trough FEV1 according to IgE level.
Time frame: Baseline, Week 6, and Week 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University