Severe AsthmaNCT05164939
Precision Medicine Intervention in Severe Asthma (PRISM) Study
An observational study of Severe Asthma, run by Asan Medical Center at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Asthma
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe asthma
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of significant pulmonary disease other than severe asthma.
- History of pulmonary eosinophilic syndrome or hyper eosinophilic syndrome.
- History of bronchopulmonary aspergillosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site, 1 recruiting
- Recruiting
Asan medical center
Seoul, Songpagu, 05505
Tae-Bum Kim, 02-3010-3287, tbkim@amc.seoul.kr
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial college
London
Kian Fan Chung
About this 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
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.
- Conditions
- Severe Asthma
- Keywords
- biologics, multi-omics analysis
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbations
Changes of number of asthma exacerbations
Measured: baseline, 1month, 6month, 10 month
Secondary outcomes (8)
Asthma symptom control
Changes in symptom score using the Asthma Control Test (ACT)
Measured: baseline, 1month, 6month, 10 month
Quality of Life Questionnaire
Change in quality of life using EuroQol-5 dimension
Measured: baseline, 1month, 6month, 10 month
Rhinosinusitis symptoms
Change in nasal symptoms using 22-item Sino-Nasal Outcome Test (SNOT-22)
Measured: baseline, 1month, 6month, 10 month
Forced Exahled Volume in 1 second (FEV1)
Changes in FEV1 in liter and % from baseline
Measured: baseline, 1month, 6month, 10 month
Forced Vital Capacity (FVC)
Changes in FVC in liter and % from baseline
Measured: baseline, 1month, 6month, 10 month
Fraction of exhaled nitric oxide, FENO
Changes in FENO in ppb
Measured: baseline, 1month, 6month, 10 month
Induced sputum eosinophil
Changes in sputum eosinophil
Measured: baseline, 1month, 6month, 10 month
Blood eosinophils
Changes in blood eosinophil
Measured: baseline, 1month, 6month, 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 May 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Bum Kim, Asan Medical Center
- Investigators
- Tae-Bum Kim, Principal investigator, Asan Medical CenterKian Fan Chung, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164939
- Sponsor's protocol ID
- 2019-1676
- Status last verified
- Dec 2021
- First submitted
- 1 Nov 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Yang F, Seo S, Hasegawa T, Bloom CI, Zounemat-Kermani N, Bhavsar PK, Raby K, Adcock IM, Won S, Kim TB, Chung KF; Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) Consortium. Longer Asthma Duration Is Associated With Elevated Non-T2 Sputum Biomarkers and Reduced T2 Inflammation in Severe Asthma. Allergy. 2026 Jul 9. doi: 10.1111/all.70436. Online ahead of print.
PubMed 42423296Lee Y, Kim H, Lee CE, Lee BJ, Kim MH, Park SY, Kim BK, Kim SH, Kim SH, Park HK, Lee T, Shim JS, Park CS, Park HK, Kwon JW, Kim S, Nam YH, Yang MS, Jung JW, Kim TB. Siglec-8 as a Biomarker for Predicting Anti-IL-5 Response in Severe Asthma. Allergy Asthma Immunol Res. 2025 Nov;17(6):742-753. doi: 10.4168/aair.2025.17.6.742.
PubMed 41330705Kang 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.
PubMed 39896201Park 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.
PubMed 39672815Pham 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.
PubMed 37977324
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05164939
- Acronym / sponsor ID
- 2019-1676
- Conditions
- Severe Asthma
- Keywords
- biologics, multi-omics analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe asthma
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma exacerbations
Time frame: baseline, 1month, 6month, 10 month
Changes of number of asthma exacerbations
8 secondary outcomes
Asthma symptom control
Time frame: baseline, 1month, 6month, 10 month
Quality of Life Questionnaire
Time frame: baseline, 1month, 6month, 10 month
Rhinosinusitis symptoms
Time frame: baseline, 1month, 6month, 10 month
Forced Exahled Volume in 1 second (FEV1)
Time frame: baseline, 1month, 6month, 10 month
Forced Vital Capacity (FVC)
Time frame: baseline, 1month, 6month, 10 month
Fraction of exhaled nitric oxide, FENO
Time frame: baseline, 1month, 6month, 10 month
Induced sputum eosinophil
Time frame: baseline, 1month, 6month, 10 month
Blood eosinophils
Time frame: baseline, 1month, 6month, 10 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 42423296Yang F, Seo S, Hasegawa T, Bloom CI, Zounemat-Kermani N, Bhavsar PK, Raby K, Adcock IM, Won S, Kim TB, Chung KF; Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) Consortium. Longer Asthma Duration Is Associated With Elevated Non-T2 Sputum Biomarkers and Reduced T2 Inflammation in Severe Asthma. Allergy. 2026 Jul 9. doi: 10.1111/all.70436. Online ahead of print.
- Derived from this study: PubMed 41330705Lee Y, Kim H, Lee CE, Lee BJ, Kim MH, Park SY, Kim BK, Kim SH, Kim SH, Park HK, Lee T, Shim JS, Park CS, Park HK, Kwon JW, Kim S, Nam YH, Yang MS, Jung JW, Kim TB. Siglec-8 as a Biomarker for Predicting Anti-IL-5 Response in Severe Asthma. Allergy Asthma Immunol Res. 2025 Nov;17(6):742-753. doi: 10.4168/aair.2025.17.6.742.
- Derived from this study: PubMed 39896201Kang 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.
- Derived from this study: PubMed 39672815Park 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.
- Derived from this study: PubMed 37977324Pham 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.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Severe Asthma
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
Asthma Acute
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Bum Kim principal investigator
Asan Medical Center
Kian Fan Chung principal investigator
Imperial College London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Asan Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Bum Kim (82-2-3010-3287, tbkim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbations (time frame: baseline, 1month, 6month, 10 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164939, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.