Precision Medicine Intervention in Severe Asthma (PRISM) Study

Last updated: December 8, 2021
Sponsor: Asan Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT05164939
2019-1676
  • Ages 18-80
  • All Genders

Study 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.

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

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.

Connect with a study center

  • Asan medical center

    Seoul, Songpagu 05505
    Korea, Republic of

    Active - Recruiting

  • Imperial college

    London,
    United Kingdom

    Active - Recruiting

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