Tokyo, June 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061809) titled 'SWITCH-26 Study: A Longitudinal Questionnaire Study on the Impact of Switching to a 26-Week Injectable Therapy on Convenience and Psychological Burden in Patients with Bronchial Asthma' on June 5.
Study Type:
Observational
Primary Sponsor:
Institute - University of Miyazaki
Condition:
Condition - Asthma
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to longitudinally evaluate changes in convenience and psychological burden in patients with bronchial asthma who switch from conventional biologic therapies to a long-acting injectable therapy administered every 26 weeks. In addition, this study aims to assess temporal changes in patient-reported outcomes, including treatment satisfaction, and to examine the impact of extended dosing intervals on patient-centered outcomes.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 20 years or older at the time of consent
Patients who have been receiving the same biologic therapy (omalizumab, mepolizumab, benralizumab, dupilumab, or tezepelumab) for at least 12 months at the time of consent
Patients who switch to a long-acting injectable therapy administered every 26 weeks
Patients who provide written informed consent after receiving sufficient explanation of the study
Key exclusion criteria - Patients who changed biologic therapy within 12 months prior to consent
Patients who received unapproved biologic therapies within 12 months prior to consent
Patients who received pharmacological treatment for malignancy within 12 months prior to consent
Patients deemed inappropriate for participation by the investigator
Target Size - 35
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 18 Day
Date of IRB - 2026 Year 05 Month 21 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070018
Disclaimer: Curated by HT Syndication.