A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)
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
1 other identifier
observational
74
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2019
CompletedFirst Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2023
CompletedJuly 23, 2024
July 1, 2024
4 years
March 5, 2021
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Changes in Post-BD FEV1
Until 24 months from baseline
Post-BD FEV1 by patient's background
Until 24 months from baseline
To compare the asthma control status between Bx reg and non-Bx reg
24 months from baseline
Daily Oral Corticosteroid use
Until 24 months from baseline
Baseline patient background and clinical presentations between Bx reg and non-Bx reg
Until 24 months from baseline
- +5 more secondary outcomes
Other Outcomes (7)
To describe baseline patients' background and clinical presentations by each biologic
Until 24 months from baseline
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
Until 24 months from baseline
- +4 more other outcomes
Study Arms (2)
Bx reg group
non-Bx reg group
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (28)
Research Site
Aki-gun Fucyu, Japan
Research Site
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 22, 2021
Study Start
December 10, 2019
Primary Completion
November 27, 2023
Study Completion
November 27, 2023
Last Updated
July 23, 2024
Record last verified: 2024-07