An Exploratory Study on Triple Inhaler Therapy in Patients With Early Lung Function Impairment (BGF-PRISm)

Inclusion Criteria:

1. Age 40-75 years;
2. Smoking history ≥10 pack-years;
3. Pulmonary function test showing 0.7 ≤ FEV1/FVC < 0.8 and FEV1 < 80% predicted;
4. Presence of at least one chronic respiratory symptom (e.g., cough, sputum, dyspnea) lasting ≥3 months;
5. Voluntarily sign a written informed consent form, be able to understand the study objectives, and comply with follow-up requirements;
6. The investigator assesses that the subject is able to complete the 12-week treatment and follow-up and has good medication adherence.

Exclusion Criteria:

1. 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/FVC < 0.7). (3) Acute respiratory infection or exacerbation within 4 weeks prior to enrollment.
2. 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.
3. 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.
4. Other Systemic Diseases: (1) Severe hepatic or renal insufficiency (ALT/AST > 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²). (2) Uncontrolled diabetes (HbA1c > 9%) or hyperthyroidism.
5. 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 < 1 year, inability to complete follow-up).