Precision Medicine Intervention in Severe Asthma (PRISM) Study

Study Overview
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Brief Summary
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The Korea-UK Precision Medicine Intervention in Severe Asthma (PRISM) study aims to identify molecular phenotypes of severe asthma by analyzing multi-omics data including genomics, epigenomics, transcriptomics, proteomics, metagenomics, and metabolomics.

Detailed Description
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This is a prospective, observational cohort study. The participants are composed of the patients having severe asthma treated with biologic agents or conventional medication. Once enrolled, regular evaluation of clinical characteristics and obtainment of samples for omics analysis is conducted to identify clinically relevance molecular signals in severe asthmatics.

Official Title
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Precision Medicine Intervention in Severe Asthma (PRISM) Study: Molecular Phenotyping of Participants With Severe Asthma to Determine Response to Biologic Therapies and Stability

Conditions
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Severe Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject aged between 18 years and 80 years Give written informed consent prior to participation in the study including all procedures Comply with study protocol requirements Able to read, comprehend, and write at a sufficient level to complete study related materials Able to complete the study and all measurements All patients have been through a severe asthma protocol that have ascertained the diagnosis of severe asthma, maximised treatments and ensured adherence to therapy. Stable asthma therapy for at least a month before screening Exclusion Criteria: As a result of medical interview, physical examination or screening investigation the investigators consider the subject unfit either because of risk to the subject due to the study or the influence this may have on the study results. A history of recreational drug use or allergy which in the opinion of the investigators 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 study procedures. Within 4 weeks of screening visit been hospitalized or required high dose oral corticosteroid (>30 mg prednisolone per day) therapy, asthma not been stable. Patients who have had prior treatment with bronchial thermoplasty, defined as completion 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma exacerbations | Changes of number of asthma exacerbations | baseline, 1month, 6month, 10 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma symptom control | Changes in symptom score using the Asthma Control Test (ACT) | baseline, 1month, 6month, 10 month | 
| Quality of Life Questionnaire | Change in quality of life using EuroQol-5 dimension | baseline, 1month, 6month, 10 month | 
| Rhinosinusitis symptoms | Change in nasal symptoms using 22-item Sino-Nasal Outcome Test (SNOT-22) | baseline, 1month, 6month, 10 month | 
| Forced Exahled Volume in 1 second (FEV1) | Changes in FEV1 in liter and % from baseline | baseline, 1month, 6month, 10 month | 
| Forced Vital Capacity (FVC) | Changes in FVC in liter and % from baseline | baseline, 1month, 6month, 10 month | 
| Fraction of exhaled nitric oxide, FENO | Changes in FENO in ppb | baseline, 1month, 6month, 10 month | 
| Induced sputum eosinophil | Changes in sputum eosinophil | baseline, 1month, 6month, 10 month | 
| Blood eosinophils | Changes in blood eosinophil | baseline, 1month, 6month, 10 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biologics, multi-omics analysis