Precision Medicine Intervention in Severe Asthma (PRISM) Study
- Conditions
- Severe Asthma
- Registration Number
- NCT05164939
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma exacerbations baseline, 1month, 6month, 10 month Changes of number of asthma exacerbations
- Secondary Outcome Measures
Name Time Method Induced sputum eosinophil baseline, 1month, 6month, 10 month Changes in sputum eosinophil
Quality of Life Questionnaire baseline, 1month, 6month, 10 month Change in quality of life using EuroQol-5 dimension
Forced Exahled Volume in 1 second (FEV1) baseline, 1month, 6month, 10 month Changes in FEV1 in liter and % from baseline
Fraction of exhaled nitric oxide, FENO baseline, 1month, 6month, 10 month Changes in FENO in ppb
Rhinosinusitis symptoms baseline, 1month, 6month, 10 month Change in nasal symptoms using 22-item Sino-Nasal Outcome Test (SNOT-22)
Forced Vital Capacity (FVC) baseline, 1month, 6month, 10 month Changes in FVC in liter and % from baseline
Asthma symptom control baseline, 1month, 6month, 10 month Changes in symptom score using the Asthma Control Test (ACT)
Blood eosinophils baseline, 1month, 6month, 10 month Changes in blood eosinophil
Trial Locations
- Locations (2)
Asan medical center
🇰🇷Seoul, Songpagu, Korea, Republic of
Imperial college
🇬🇧London, United Kingdom