Clinical effects and biomarkers of biological agents on asthma

JRCT ID: jRCT1031190033

Registered date:28/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 25/07/2019
• Target sample size: 45
• Study type: Interventional
• Intervention(s): none

Outcome(s)

• Primary Outcome: Asthma control questionnaire (ACQ)
• Secondary Outcome: Respiratory function test, SABA usage, acute exacerbation, serum biomarker (IL-5, etc)

Key inclusion & exclusion criteria

• Age minimum: 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Asthma patients diagnosed based on Japanese Asthma Prevention and Management Guideline 2018 who are older than 12 years old
2) Either anti-IgE antibody (Zorea), anti-IL-5 antibody (Nucala), or anti-IL-5 receptor antibody (Facenra) is going to be administered.
3) Written informed consent from the patients or the legal gardian is obtained.

Exclude criteria

1) Those patients who can not be taken blood sample
2) Those patients who were judged not suitable for the entry to this investigation be the responsible doctor

Related Information

• Primary Sponsor: MORI AKIO
• Source(s) of Monetary Support: National Hospital Organization