Objectives in this study is to compare the change of lung function after 24 months from baseline between the two groups; one is the patient group who decided to start biologics treatment, and another is the patient group who decided to start non-biologics treatment. The target patients are the adult uncontrolled severe asthma patients.
Study Type
OBSERVATIONAL
Enrollment
74
Research Site
Aki-gun Fucyu, Japan
Research Site
Asahikawa, Japan
Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1)
Change from baseline in post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) at 24 months
Time frame: 24 months from baseline
Changes in Post-BD FEV1
To describe the value of lung function decline in Bx reg and non-Bx reg by changes in Post-BD FEV1 from 6 months to 24 months, and from 12 months to 24 months
Time frame: Until 24 months from baseline
Post-BD FEV1 by patient's background
Change from baseline in post-bronchodilator FEV1 at 24 months by patient's background, To compare the differences of change from baseline in post-BD FEV1 at 24 months between Bx reg and non-Bx reg, by the following patients' sub-groups 1. Number of exacerbations during the study period (0, 1-2, 3-4, \>= 5) 2. asthma control level (mean ACQ-5 score between 6 months and 24 months; \<0.75, 0.75 - 1.5, \>1.5)
Time frame: Until 24 months from baseline
To compare the asthma control status between Bx reg and non-Bx reg
To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg -ACQ-5,Time to first asthma exacerbation and so on
Time frame: 24 months from baseline
Daily Oral Corticosteroid use
Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use
Time frame: Until 24 months from baseline
Baseline patient background and clinical presentations between Bx reg and non-Bx reg
To describe the baseline patient background and clinical presentations between Bx reg and non-Bx reg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Bunkyō City, Japan
Research Site
Fukuoka, Japan
Research Site
Hamamatsu, Japan
Research Site
Hiroshima, Japan
Research Site
Ikoma, Japan
Research Site
Kobe, Japan
Research Site
Kumagaya, Japan
Research Site
Maebashi, Japan
...and 18 more locations
Time frame: Until 24 months from baseline
MiniAQLQ score
To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months
Time frame: Until 24 months from baseline
ACQ-5 score
To compare the differences of change from baseline in ACQ-5 score at 12 months and 24 months between both groups. To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by ACQ-5 score.
Time frame: 24 months from baseline
Time to first asthma exacerbation
To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Time to first asthma exacerbation
Time frame: 24 months from baseline
Annual rate of asthma exacerbations
To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Annual rate of asthma exacerbations
Time frame: 24 months from baseline
Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)
To compare the asthma control status during the study period (24 months) between Bx reg and non-Bx reg by Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)
Time frame: 24 months from baseline