Clinical trial NCT04808518: A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (Post-BD FEV1)
timeFrame: 24 months from baseline
Secondary outcomes:
measure: Changes in Post-BD FEV1
timeFrame: Until 24 months from baseline
measure: Post-BD FEV1 by patient's background
timeFrame: Until 24 months from baseline
measure: To compare the asthma control status between Bx reg and non-Bx reg
timeFrame: 24 months from baseline
measure: Daily Oral Corticosteroid use
timeFrame: Until 24 months from baseline
measure: Baseline patient background and clinical presentations between Bx reg and non-Bx reg
timeFrame: Until 24 months from baseline
measure: MiniAQLQ score
timeFrame: Until 24 months from baseline
measure: ACQ-5 score
timeFrame: 24 months from baseline
measure: Time to first asthma exacerbation
timeFrame: 24 months from baseline
measure: Annual rate of asthma exacerbations
timeFrame: 24 months from baseline
measure: Asthma-specific resource utilisation (Hospital visits, ER/urgent care visits, hospitalisations)
timeFrame: 24 months from baseline
Other outcomes:
measure: To describe baseline patients' background and clinical presentations by each biologic
timeFrame: Until 24 months from baseline
measure: Blood eosinophil counts, FeNO, Atopic factor, IgE in non-Bx reg
timeFrame: Until 24 months from baseline
measure: Time to decrease 0.5 (at least) of ACQ-5 score and duration of asthma
timeFrame: Until 24 months from baseline
measure: Treatment reality of each biologic
timeFrame: Until 24 months from baseline
measure: To describe the change of asthma control status after switching one biologic to other biologics by ACQ-5 score status
timeFrame: Until 24 months from baseline
measure: To explore the factors related to non-responder in Bx reg group
timeFrame: Until 24 months from baseline
measure: Reason why biologics are not started within 12 weeks in non-Bx reg group
timeFrame: within 12 weeks from study start
Locations:
city: Aki-gun Fucyu
country: Japan
facility: Research Site
city: Asahikawa
country: Japan
facility: Research Site
city: Bunkyo
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hamamatsu
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Ikoma
country: Japan
facility: Research Site
city: Itabashi
country: Japan
facility: Research Site
city: Kobe
country: Japan
facility: Research Site
city: Kumagaya
country: Japan
facility: Research Site
city: Maebashi
country: Japan
facility: Research Site
city: Meguro
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Nangoku
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osakasayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Otsu
country: Japan
facility: Research Site
city: Sagamihara
country: Japan
facility: Research Site
city: Shinagawa
country: Japan
facility: Research Site
city: Shinjuku
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Toyoake
country: Japan
facility: Research Site
city: Tsukubo-gun Hayashima
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yokohama
country: Japan
facility: Research Site
city: Yonago
country: Japan
facility: Research Site
Study officials:
References: