NCT06438913Not yet recruiting
Tezepelumab Treatment in Korean Severe Asthma Patients
The Improvement of Cough Outcomes After Tezepelumab Treatment in Korean Severe Asthma Patients With Airway Hyperresponsiveness
Source: ClinicalTrials.gov · Last updated 3 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 17 May 2024
- Start date
- 12 Jun 2024
- Primary completion date
- 12 May 2025
- Lead sponsor
- Asan Medical Center
- Diseases
- Asthma
- NCT number
- NCT06438913
What you commit to
- Study type: Observational
- Planned participants: 100
- From 12 Jun 2024 to the primary completion date, 12 May 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Age
- Minors under 19 years of age, senior citizens over 79 years of age
Other
- Pregnant women
Who the study is looking for
- 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)
Age in the registry: 19 years to 79 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.