Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma

Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma - Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050222

Enrollment

Registered

2023-02-03

Start date

2023-02-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Cough predominant asthma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with asthma who are scheduled to receive tezepelumab. 2) Patients with asthma who are at least 18 years old and less than 85 years old on the date of enrollment. 3) Patients with asthma who have given their written consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Patients with other obvious respiratory complications such as lung cancer, interstitial lung disease, etc. 2) Pregnant or lactating patients. 3) Patients who are judged to be inappropriate as subjects by the principal investigator.

Design outcomes

Primary

Measure	Time frame
To identify predictors of effectiveness at 6 and 12 months after the initiation of tezepelumab.	—

Secondary

Measure	Time frame
1) To identify predictors of effectiveness to cough by classifying patients with asthma into "antitussive group" and "non-tussive group" at 6 and 12 months after the initiation of tezepelumab. 2) To evaluate the effect of tezepelumab on capsaicin cough sensitivity at 6 and 12 months after the initiation of treatment. 3) To evaluate the effect of tezepelumab on functional dyspepsia symptoms, gastroesophageal reflux symptoms, and abnormal laryngeal sensation symptoms at 6 and 12 months after the initiation of treatment. 4) To evaluate the effect of tezepelumab at 6 and 12 months after the initiation of treatment, based on the inflammation phenotypes using baseline induced sputum fractions and peripheral blood eosinophil/neutrophil counts.	—

Measure

Time frame

1) To identify predictors of effectiveness to cough by classifying patients with asthma into "antitussive group" and "non-tussive group" at 6 and 12 months after the initiation of tezepelumab. 2) To evaluate the effect of tezepelumab on capsaicin cough sensitivity at 6 and 12 months after the initiation of treatment. 3) To evaluate the effect of tezepelumab on functional dyspepsia symptoms, gastroesophageal reflux symptoms, and abnormal laryngeal sensation symptoms at 6 and 12 months after the initiation of treatment. 4) To evaluate the effect of tezepelumab at 6 and 12 months after the initiation of treatment, based on the inflammation phenotypes using baseline induced sputum fractions and peripheral blood eosinophil/neutrophil counts.

—

Countries

Japan

Contacts

Public ContactYoshihiro Kanemitsu

Nagoya City University Graduate School of Medical Sciences Department of Respiratory Medicine, Allergy and Clinical Immunology

kaney32@med.nagoya-cu.ac.jp052-853-8216

Outcome results