Clinical trial NCT05164939: Precision Medicine Intervention in Severe Asthma (PRISM) Study
Official title: Precision Medicine Intervention in Severe Asthma (PRISM) Study: Molecular Phenotyping of Participants With Severe Asthma to Determine Response to Biologic Therapies and Stability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Asthma
Keywords: biologics, multi-omics analysis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe asthma

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma exacerbations
timeFrame: baseline, 1month, 6month, 10 month
Secondary outcomes:
measure: Asthma symptom control
timeFrame: baseline, 1month, 6month, 10 month
measure: Quality of Life Questionnaire
timeFrame: baseline, 1month, 6month, 10 month
measure: Rhinosinusitis symptoms
timeFrame: baseline, 1month, 6month, 10 month
measure: Forced Exahled Volume in 1 second (FEV1)
timeFrame: baseline, 1month, 6month, 10 month
measure: Forced Vital Capacity (FVC)
timeFrame: baseline, 1month, 6month, 10 month
measure: Fraction of exhaled nitric oxide, FENO
timeFrame: baseline, 1month, 6month, 10 month
measure: Induced sputum eosinophil
timeFrame: baseline, 1month, 6month, 10 month
measure: Blood eosinophils
timeFrame: baseline, 1month, 6month, 10 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Songpagu
city: London
country: United Kingdom
facility: Imperial college
Study officials:
affiliation: Asan Medical Center
name: Tae-Bum Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Kian Fan Chung
role: PRINCIPAL_INVESTIGATOR
References: