Preserved ratio impaired spirometry
Conditions
Interventions
Budesonide/glycopyrronium/formoterol treatment group:budesonide/glycopyrronium bromide/formoterol inhalation aerosol
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 40-75 years; 2.Smoking history >=10 pack-years; 3.Pulmonary function test showing 0.7 = FEV1/FVC =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
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 =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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough forced expiratory volume in the first second (trough FFEV1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Saint George's Respiratory Questionnaire (SGRQ) Score;Adverse events (AEs) and serious adverse events (SAEs);COPD Assessment Test (CAT) Score; | — |
Countries
China
Contacts
Public ContactZhuansun Yongxun
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed