A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Primary Data Collection Study to Compare the Lung Function in the Adult Severe Asthma Patients Who Start Biologics Treatment and Who do Not Start, After Two-year Follow-up

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed asthma diagnosis Using high-dose ICSa and 2nd controllerb more than 3 months before registration Uncontrolled asthma which constitutes one or more of 1) Poor symptom control: ACQ-5≧1.5 or ATC<20 2) Frequent exacerbations: at least 2 asthma exacerbations in the 12 months prior to the registration 3) Airflow obstruction: FEV1 before taking bronchodilator <80% predicted (FEV1/FVC less than the lower limit of normal) C Investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators. Patients deemed capable of visiting their study site next 24 months regularly Patients from whom written consent to participate in this study has been obtained Patients≧20 years old at obtaining consent 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: Affect the safety of the patient throughout the study Influence the findings of the studies or their interpretations Impede the patient's ability to complete the entire duration of study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bx reg group<br> | |
| non-Bx reg group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 Number of exacerbations during the study period (0, 1-2, 3-4, >= 5) asthma control level (mean ACQ-5 score between 6 months and 24 months; <0.75, 0.75 - 1.5, >1.5) | 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 |