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NCT Number: NCT06438913

Tezepelumab Treatment in Korean Severe Asthma Patients

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • ACT score less than 20 or 'not well controlled' according to GINA guideline
  • frequent exacerbations; Requires systemic steroid administration (over 3 consecutive days) more than twice in the previous year If you did
  • 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
  • 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

Treatment and study plan

Tezepelumab

Drug

Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine suggested to be important in the initiation and continuation of airway inflammation.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 3, 2024
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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