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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bx reg group | |||
| non-Bx reg group |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Until 24 months from baseline |
| Post-BD FEV1 by patient's background |
| Measure | Description | Time Frame |
|---|---|---|
| To describe baseline patients' background and clinical presentations by each biologic | To describe baseline patients' background and clinical presentations by each biologic - Age, sex, , BMI, smoking history, history of pediatric asthma, duration of asthma, complications, comorbidities, blood eosinophils, FeNO, IgE, Atopic factor, etc. | Until 24 months from baseline |
Inclusion Criteria:
Exclusion Criteria:
Participated in other interventional studies such as clinical trials, etc within the last 8 weeks.
Are using biologics at registration
Diagnosed as COPD
Plan the BT therapy near future
Receipt of any marketed or investigational biologics within 5 months before the registration
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
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Target patients in this study are the adult severe asthma patients whose asthma control status is uncontrolled based on the definition of ERS/ATS guideline. Also, the investigators judge the necessity of biologic treatment and explain the situation to these patient population.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aki-gun Fucyu | Japan | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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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
|
| 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 | 24 months from baseline |
| Daily Oral Corticosteroid use | Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use | 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 | Until 24 months from baseline |
| MiniAQLQ score | To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months | 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. | 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 | 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 | 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) | 24 months from baseline |
| Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg | To describe the proportion of these patient population in non-Bx reg; Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg | Until 24 months from baseline |
| Time to decrease 0.5 (at least) of ACQ-5 score and duration of asthma | To evaluate the association between the time to decrease 0.5 of ACQ-5 and duration of asthma (< 10 years, 10<= and < 20 years, 20<= and < 30 years, >= 30 years) | Until 24 months from baseline |
| Treatment reality of each biologic | To describe the following information in Bx reg during the observational period
| Until 24 months from baseline |
| To describe the change of asthma control status after switching one biologic to other biologics by ACQ-5 score status | To describe the change of asthma control status after switching one biologic to other biologics by the following ACQ-5 score status
| Until 24 months from baseline |
| To explore the factors related to non-responder in Bx reg group | To explore the factors related to non-responder at 24 months in Bx reg group (Definition of non-responder; ACQ-5 score decrease from the baseline is no more than 0.5[<0.5] ) | Until 24 months from baseline |
| Reason why biologics are not started within 12 weeks in non-Bx reg group | To describe the reason why biologics are not started within 12 weeks in non-Bx reg group. | within 12 weeks from study start |
| Asahikawa |
| Japan |
| 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 |
| Research Site | Meguro City | Japan |
| Research Site | Nagoya | Japan |
| Research Site | Nangōku | Japan |
| Research Site | Niigata | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōtsu | Japan |
| Research Site | Sagamihara | Japan |
| Research Site | Sayama | Japan |
| Research Site | Shinagawa City | Japan |
| Research Site | Shinjuku | Japan |
| Research Site | Shizuoka | Japan |
| Research Site | tabashi City | Japan |
| Research Site | Toyoake | Japan |
| Research Site | Tsukubo-gun Hayashima | Japan |
| Research Site | Yamagata | Japan |
| Research Site | Yokohama | Japan |
| Research Site | Yonago | Japan |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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