COPD exacerbation
Conditions
Brief summary
Reduction of the number of moderate (to be treated at home) and severe (hospital) exacerbations at 12 months.
Detailed description
• Reduction of RTIs (patient-reported) • Adverse Event (AE) • Study discontinuation due to AEs, • Assessment if COPD exacerbations were triggered by RTIs, • Improvement in 6MWD compared at baseline and end of study, • Improvement of dyspnoe compared at baseline and end of study mMRC scale results., • Reduction of COPD associated symptoms by Broncho-Vaxom • body plethysmography • diffusion capacity test (FEV 1, FVC, FEV 1/FVC, TLC, VC, FRC, RV, DL, CO) • Omron BF511 (mainly fat-free body mass) • CAT-COPD Assessment Test • CCQ-Chronic COPD Questionnaire
Interventions
DRUGBroncho-Vaxom OM kemény kapszula felnőtteknek
DRUGPowder without active ingredient.
Sponsors
Semmelweis University, University Of Pecs
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the number of moderate (to be treated at home) and severe (hospital) exacerbations at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Reduction of RTIs (patient-reported) • Adverse Event (AE) • Study discontinuation due to AEs, • Assessment if COPD exacerbations were triggered by RTIs, • Improvement in 6MWD compared at baseline and end of study, • Improvement of dyspnoe compared at baseline and end of study mMRC scale results., • Reduction of COPD associated symptoms by Broncho-Vaxom • body plethysmography • diffusion capacity test (FEV 1, FVC, FEV 1/FVC, TLC, VC, FRC, RV, DL, CO) • Omron BF511 (mainly fat-free body mass) • CAT-COPD Assessment Test • CCQ-Chronic COPD Questionnaire | — |
Outcome results
None listed