A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)
NCT ID: NCT04808518
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
74 participants
OBSERVATIONAL
2019-12-10
2023-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bx reg group
No interventions assigned to this group
non-Bx reg group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Related Links
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Other Identifiers
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D3250R00062
Identifier Type: -
Identifier Source: org_study_id
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