Precision Medicine Intervention in Severe Asthma (PRISM) Study

Severe Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164939
• Other study ID #: 2019-1676
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Asan Medical Center
• Contact: Tae-Bum Kim
• Phone: 82-2-3010-3287
• Email: tbkim[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul	Songpagu
United Kingdom	Imperial college	London

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Countries where clinical trial is conducted

Korea, Republic of,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma exacerbations	Changes of number of asthma exacerbations	baseline, 1month, 6month, 10 month
Secondary	Asthma symptom control	Changes in symptom score using the Asthma Control Test (ACT)	baseline, 1month, 6month, 10 month
Secondary	Quality of Life Questionnaire	Change in quality of life using EuroQol-5 dimension	baseline, 1month, 6month, 10 month
Secondary	Rhinosinusitis symptoms	Change in nasal symptoms using 22-item Sino-Nasal Outcome Test (SNOT-22)	baseline, 1month, 6month, 10 month
Secondary	Forced Exahled Volume in 1 second (FEV1)	Changes in FEV1 in liter and % from baseline	baseline, 1month, 6month, 10 month
Secondary	Forced Vital Capacity (FVC)	Changes in FVC in liter and % from baseline	baseline, 1month, 6month, 10 month
Secondary	Fraction of exhaled nitric oxide, FENO	Changes in FENO in ppb	baseline, 1month, 6month, 10 month
Secondary	Induced sputum eosinophil	Changes in sputum eosinophil	baseline, 1month, 6month, 10 month
Secondary	Blood eosinophils	Changes in blood eosinophil	baseline, 1month, 6month, 10 month