Chronic obstructive pulmonary disease
Conditions
Interventions
Treatment group:Umeclidinium/Vilanterol Inhalation Powder (umeclidinium 62.5 µg and vilanterol 25 µg), once daily, one inhalation per dose
As-needed salbutamol.
Untreated control group:No additional drug intervention, only as-needed salbutamol inhalation therapy.
Sponsors
THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 40 and 80 years (inclusive), either male or female. 2.Currently in a stable condition: No acute respiratory events within 4 weeks prior to screening or during the screening period. 3.Spirometry performed during the V0 screening meet the following criteria after inhalation of 400 µg salbutamol: FEV1/FVC = 0.70 and FEV1 < 80% of the predicted value. 4.Ability to correctly use the inhalation device after training. 5.Voluntary participation and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Recent respiratory diseases: acute upper or lower respiratory tract infections requiring antibiotic treatment within 4 weeks prior to screening; 2. Other respiratory diseases: Clinically significant a-1 antitrypsin deficiency, cystic fibrosis, asthma, active bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disease, bronchiolitis obliterans and active pulmonary tuberculosis, restrictive lung disease, etc.; 3. Major cardiovascular disease: Previous or current severe cardiovascular disease, including but not limited to: congestive heart failure, uncontrolled hypertension (two or more consecutive tests of systolic blood pressure > 160 mmHg, or diastolic pressure > 100 mmHg, etc.), clinically significant coronary disease (such as patients with coronary heart disease requiring long-term maintenance treatment with coronary dilators), myocardial infarction within 6 months, stroke within 6 months, known aortic aneurysm, clinically significant arrhythmias (ventricular rate > 120 bpm atrial fibrillation, persistent or non-persistent ventricular tachycardia, sinus bradycardia with a ventricular rate of 12 hours daily) or mechanical ventilation; 11. History of allergies: Known allergy to ß2 receptor agonists, M receptor antagonists, and excipients of investigational drugs; 12. Abnormal screening tests; 13. Significant liver or kidney dysfunction: ALT, AST, > twice the upper limit of normal, or Cr 1.5 times the upper limit of normal; 14. Serum potassium 450 ms in men or 470 ms >in women, or e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 from baseline before inhaling a bronchodilator after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Carbon dioxide ventilation equivalent (VE/VCO2), peak oxygen uptake (VO2peak), work rate, and dynamic hyperinflation (change in inspiratory capacity from rest to peak exercise, ?IC(peak-rest)).;Prebronchodilator small airway resistance (R5–R20); proportion of subjects with prebronchodilator R5–R20 >0.07 kPa/L/s; and diffusing capacity of the lung for carbon monoxide (DLco).;Prebronchodilator MMEF, FEF50, and FEF75 as percentages of predicted values; proportion of subjects with at least two of these three indicators (MMEF, FEF50, FEF75) <65% of predicted values.;Average daily use of rescue medication (Salbutamol Sulphate Aerosol) (puffs/day).;Prebronchodilator and postbronchodilator FVC;Postbronchodilator FEV1;PRMfSAD: proportion of subjects with PRMfSAD =15%; inspiratory phase CT total lung capacity (TLC); expiratory phase CT residual volume (RV); and PRMEmph;scale score; | — |
Countries
China
Contacts
Public ContactFan Wu
THE FIRST AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY
Outcome results
None listed