Last updated: December 8, 2021
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Asthma
Treatment
N/AClinical Study ID
NCT05164939
2019-1676
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subject aged between 18 years and 80 years
- Give written informed consent prior to participation in the study including allprocedures
- Comply with study protocol requirements
- Able to read, comprehend, and write at a sufficient level to complete study relatedmaterials
- Able to complete the study and all measurements
- All patients have been through a severe asthma protocol that have ascertained thediagnosis of severe asthma, maximised treatments and ensured adherence to therapy.
- Stable asthma therapy for at least a month before screening
Exclusion
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigation theinvestigators consider the subject unfit either because of risk to the subject due tothe study or the influence this may have on the study results.
- A history of recreational drug use or allergy which in the opinion of theinvestigators contraindicates their participation.
- Participation within 3 months in any a trial testing a new molecular entity or drug.
- Those, in the opinion of the investigator, who may prove non-compliant with studyprocedures.
- Within 4 weeks of screening visit been hospitalized or required high dose oralcorticosteroid (>30 mg prednisolone per day) therapy, asthma not been stable.
- Patients who have had prior treatment with bronchial thermoplasty, defined ascompletion of all thermoplasty treatment sessions within 6 months of screening
- History of significant pulmonary disease other than severe asthma.
- History of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome.
- History of bronchopulmonary aspergillosis
Study Design
Total Participants: 200
Study Start date:
May 01, 2020
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Asan medical center
Seoul, Songpagu 05505
Korea, Republic ofActive - Recruiting
Imperial college
London,
United KingdomActive - Recruiting
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