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
Sponsor study identifier
observational
74
1 country
28
Study Start
December 10, 2019
Actual (reported)Primary Completion
November 27, 2023
Actual (reported)Study Completion
November 27, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 27, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2019
Actual (reported)March 5, 2021
Actual (reported)March 22, 2021
Actual (reported)November 27, 2023
Actual (reported)November 27, 2023
Actual (reported)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
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
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
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.
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
74 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2021
First Posted
March 22, 2021
Study Start
December 10, 2019
Actual (reported)Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
Contact the study team to confirm eligibility.
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
Primary Completion
November 27, 2023
Actual (reported)Study Completion
November 27, 2023
Actual (reported)Last Updated
July 23, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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