Tezepelumab Treatment in Korean Severe Asthma Patients

May 27, 2024 updated by: Tae-Bum Kim, Asan Medical Center

The Improvement of Cough Outcomes After Tezepelumab Treatment in Korean Severe Asthma Patients With Airway Hyperresponsiveness

There is no study that systematically evaluated the effect of Tezepelumab on cough, and based on this background, the present researchers aimed to evaluate the effect of Tezepelumab treatment in patients with severe asthma who complain of cough using the Leicester Cough Questionnaire, a cough-related quality of life measurement tool.

Study Overview

Status

Not yet recruiting

Conditions

Asthma

Intervention / Treatment

Drug: Tezepelumab

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Description

Inclusion Criteria:

Severe asthma patients aged 19 or older and 79 or younger
Cases diagnosed as asthma by an expert and classified as severe asthma according to the 2014 ATS/ERS guidelines
- Patients who require the use of high-dose inhaled steroids and additional control agents or systemic steroids for more than 50% of the year to control symptoms. Or, if asthma is not controlled even with the medication. Here, uncontrolled asthma means that any one of the following is satisfied.
1. ACT score less than 20 or 'not well controlled' according to GINA guideline
2. frequent exacerbations; Requires systemic steroid administration (over 3 consecutive days) more than twice in the previous year If you did
3. severe exacerbation; A condition that required hospitalization, admission to an intensive care unit, or application of a ventilator in the previous year If you have been angry at least once
4. airflow restrictions; FEV1 < 80%
If a cough is due to asthma according to a doctor and the cough onset scale (cough visual analogue scale, cough VAS) satisfies 30 or more points out of 100.
If a positive result is confirmed in the methacholine (or mannitol) bronchial challenge test (if the bronchial challenge test result is not available or the test is difficult to proceed, it can be replaced with a positive bronchodilator response test)

Exclusion Criteria:

Minors under 19 years of age, senior citizens over 79 years of age
If there is a history of use of other biological agents within 3 months prior to study registration
Cases where there was an acute exacerbation requiring a steroid burst (total 90mg prednisolone or more) during the 4-week screening period before study registration (possible for long-term prednisolone users)
Cases accompanied by clinically serious respiratory disease in addition to severe asthma
When accompanied by hypereosinophilic syndrome, ABPA, EGPA
When it is difficult to evaluate asthma alone due to severe respiratory disease
Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Tezepeluma on Cough Time Frame: 1years	The effectiveness of Tezepelumab on cough was assessed by comparing the LCQ score at 1 and 12 months of administration with the LCQ score at the time of registration.	1years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 12, 2024

Primary Completion (Estimated)

May 12, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)