Precision Medicine Intervention in Severe Asthma (PRISM) Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Asthma

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Tae-Bum Kim; Phone Number: 82-2-3010-3287; Email: tbkim@amc.seoul.kr
• Study Contact Backup: Name: Ji-Hyang Lee; Phone Number: 82-2-3010-1821; Email: gogoportia@gmail.com

Study Locations

• Korea, Republic of
  • Songpagu
    • Seoul, Songpagu, Korea, Republic of, 05505
      • Recruiting
      • Asan Medical Center
      • Contact: Tae-Bum Kim; Phone Number: 02-3010-3287; Email: tbkim@amc.seoul.kr
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Imperial College
    • Contact: Kian Fan Chung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe asthma

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Tae-Bum Kim, Asan Medical Center; Principal Investigator: Kian Fan Chung, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: biologics, multi-omics analysis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2019-1676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No