Asthma
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Confirmed asthma diagnosis 2. Using high-dose ICSa and 2nd controllerb more than 3 months before registration 3. 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 4. Investigators judges the necessity of biologic treatment for his/her asthma treatment and the patients are explained the situation by the investigators. 5. Patients deemed capable of visiting their study site next 24 months regularly 6. Patients from whom written consent to participate in this study has been obtained 7. Patients≧20 years old at obtaining consent
Exclusion criteria
1. Participated in other interventional studies such as clinical trials, etc within the last 8 weeks. 2. Are using biologics at registration 3. Diagnosed as COPD 4. Plan the BT therapy near future 5. Receipt of any marketed or investigational biologics within 5 months before the registration 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) | 24 months from baseline | Change from baseline in post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1) at 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare the asthma control status between Bx reg and non-Bx reg | 24 months from baseline | 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 |
| Daily Oral Corticosteroid use | Until 24 months from baseline | Change from baseline in daily Oral Corticosteroid dose, Time to withdraw regular Oral Corticosteroid use |
| Baseline patient background and clinical presentations between Bx reg and non-Bx reg | Until 24 months from baseline | To describe the baseline patient background and clinical presentations between Bx reg and non-Bx reg |
| MiniAQLQ score | Until 24 months from baseline | To compare the differences of change from baseline in MiniAQLQ score between both groups at 24 months |
| ACQ-5 score | 24 months from baseline | 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 to first asthma exacerbation | 24 months from baseline | 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 |
| Annual rate of asthma exacerbations | 24 months from baseline | 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 |
| Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations) | 24 months from baseline | 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) |
| Changes in Post-BD FEV1 | Until 24 months from baseline | 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 |
| Post-BD FEV1 by patient's background | Until 24 months from baseline | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to decrease 0.5 (at least) of ACQ-5 score and duration of asthma | Until 24 months from baseline | 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) |
| Treatment reality of each biologic | Until 24 months from baseline | To describe the following information in Bx reg during the observational period * Reason why a biologic is switched to another biologic * Time to switch the biologic * Specific biologic at the first time, at the 2nd time, etc. * Chronological change of proportion of prescribed each biologic during the observational period |
| To describe the change of asthma control status after switching one biologic to other biologics by ACQ-5 score status | Until 24 months from baseline | To describe the change of asthma control status after switching one biologic to other biologics by the following ACQ-5 score status * ACQ-5 responder rate (respond; decrease of more than 0.5 score) * Proportion of the following category by ACQ-5 score change pre/post switching (improve: -0.5 =\<, no-change: -0.5\< ACQ-5 \<0.5, worse: \>=0.5) |
| To explore the factors related to non-responder in Bx reg group | Until 24 months from baseline | 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\[\<0.5\] ) |
| Reason why biologics are not started within 12 weeks in non-Bx reg group | within 12 weeks from study start | To describe the reason why biologics are not started within 12 weeks in non-Bx reg group. |
| To describe baseline patients' background and clinical presentations by each biologic | Until 24 months from baseline | 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. |
| Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg | Until 24 months from baseline | To describe the proportion of these patient population in non-Bx reg; Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg |
Countries
Japan
Outcome results
None listed