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Precision Medicine Intervention in Severe Asthma (PRISM) Study

NCT ID: NCT05164939

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-12-31

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.

Conditions

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Severe Asthma

Keywords

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biologics, multi-omics analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Bum Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Bum Kim

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Kian Fan Chung

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Asan medical center

Seoul, Songpagu, South Korea

Site Status RECRUITING

Imperial college

London, , United Kingdom

Site Status RECRUITING

Countries

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South Korea United Kingdom

Central Contacts

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Tae-Bum Kim

Role: CONTACT

Phone: 82-2-3010-3287

Email: [email protected]

Ji-Hyang Lee

Role: CONTACT

Phone: 82-2-3010-1821

Email: [email protected]

Facility Contacts

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Tae-Bum Kim

Role: primary

Kian Fan Chung

Role: primary

References

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Kang YR, Kim H, Lee CE, Jung JW, Moon JY, Park SY, Kim SH, Yang MS, Kim BK, Kwon JW, Park HK, Nam YH, Cho YJ, Lee T, Adcock IM, Bhavsar P, Chung KF, Kim TB. Serum and urine eosinophil-derived neurotoxin (EDN) levels predict biologic response in severe asthma. World Allergy Organ J. 2025 Jan 9;18(1):100990. doi: 10.1016/j.waojou.2024.100990. eCollection 2025 Jan.

Reference Type DERIVED
PMID: 39896201 (View on PubMed)

Park K, Lee JH, Shin E, Jang HY, Song WJ, Kwon HS, Cho YS, Lee JE, Adcock I, Chung KF, Lee JS, Won S, Kim TB. Single-cell RNA sequencing reveals transcriptional changes in circulating immune cells from patients with severe asthma induced by biologics. Exp Mol Med. 2024 Dec;56(12):2755-2762. doi: 10.1038/s12276-024-01368-y. Epub 2024 Dec 13.

Reference Type DERIVED
PMID: 39672815 (View on PubMed)

Pham DD, Lee JH, Kwon HS, Song WJ, Cho YS, Kim H, Kwon JW, Park SY, Kim S, Hur GY, Kim BK, Nam YH, Yang MS, Kim MY, Kim SH, Lee BJ, Lee T, Park SY, Kim MH, Cho YJ, Park C, Jung JW, Park HK, Kim JH, Moon JY, Adcock I, Bhavsar P, Chung KF, Kim TB. Prospective direct comparison of biologic treatments for severe eosinophilic asthma: Findings from the PRISM study. Ann Allergy Asthma Immunol. 2024 Apr;132(4):457-462.e2. doi: 10.1016/j.anai.2023.11.005. Epub 2023 Nov 17.

Reference Type DERIVED
PMID: 37977324 (View on PubMed)

Other Identifiers

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2019-1676

Identifier Type: -

Identifier Source: org_study_id