CClinicalTrials.gg
Status unknownNCT05164939Updated Dec 21, 2021

Precision Medicine Intervention in Severe Asthma (PRISM) Study

An observational study in Severe Asthma, sponsored by Asan Medical Center. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-21.

Sponsored by Asan Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Severe Asthma

Browse trials for

Keywords

  • biologics, multi-omics analysis
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 200 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with severe asthma

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Asthma exacerbations

    Changes of number of asthma exacerbations

    Time frame: baseline, 1month, 6month, 10 month

Secondary outcomes

  1. Asthma symptom control

    Changes in symptom score using the Asthma Control Test (ACT)

    Time frame: baseline, 1month, 6month, 10 month

  2. Quality of Life Questionnaire

    Change in quality of life using EuroQol-5 dimension

    Time frame: baseline, 1month, 6month, 10 month

  3. Rhinosinusitis symptoms

    Change in nasal symptoms using 22-item Sino-Nasal Outcome Test (SNOT-22)

    Time frame: baseline, 1month, 6month, 10 month

  4. Forced Exahled Volume in 1 second (FEV1)

    Changes in FEV1 in liter and % from baseline

    Time frame: baseline, 1month, 6month, 10 month

  5. Forced Vital Capacity (FVC)

    Changes in FVC in liter and % from baseline

    Time frame: baseline, 1month, 6month, 10 month

  6. Fraction of exhaled nitric oxide, FENO

    Changes in FENO in ppb

    Time frame: baseline, 1month, 6month, 10 month

  7. Induced sputum eosinophil

    Changes in sputum eosinophil

    Time frame: baseline, 1month, 6month, 10 month

  8. Blood eosinophils

    Changes in blood eosinophil

    Time frame: baseline, 1month, 6month, 10 month

07

Study locations

2 of 2 sites recruiting
  • Asan medical center
    Seoul, Songpagu 05505, Korea, Republic of
    Recruiting
  • Imperial college
    London, United Kingdom
    • Kian Fan Chung · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05164939
Lead sponsor
Asan Medical Center
Responsible party
Tae-Bum Kim (Professor, Asan Medical Center) — Principal investigator
First posted
Dec 21, 2021
Start date
May 1, 2020
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Dec 21, 2021

Study contacts

Tae-Bum Kim
Contact
tbkim@amc.seoul.kr
82-2-3010-3287
Ji-Hyang Lee
Contact
gogoportia@gmail.com
82-2-3010-1821
Tae-Bum Kim
principal investigator · Asan Medical Center
Kian Fan Chung
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion