NCT06026202

Brief Summary

This study aims to investigate the role of IL-5 in suppressing anti-viral immune responses in bronchial epithelial cells (BECs) and in peripheral blood mononuclear cells (PBMCs) from 5 people with asthma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

August 25, 2023

Last Update Submit

October 26, 2023

Conditions

Asthma

Keywords

Interleukin 5Bronchial epithelial cellsPeripheral blood mononuclear cellsPeripheral dendritic cellsInterferonRhinovirus

Outcome Measures

Primary Outcomes (1)

  • IL-5 suppresses anti-viral immunity in BECs and in PBMCs/pDCs directly via IL-5 receptor signalling suppressing RV induction of IFNs.

    Expression of IL-5RA, CSF2RB and IFN mRNA and protein in BECs and PBMCs will be measured at baseline and following rhinovirus infection.Viral load will be measured by PCR(copies/ml) of viral RNA in cell lysates and virus release into supernatants by TCID50 assay to determine whether IL-5 augments virus replication.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with mild asthma on as required salbutamol only.

Must be eligible for the study 'Mechanisms of Adverse Effects of Long-Acting Beta-Agonists in Asthma' (MAELABA) (19SM5101).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W2 1NY, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells Bronchial epithelial cells

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Sebastian L Johnston, MBBS

CONTACT

+44 20 7594 3764s.johnston@imperial.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

September 7, 2023

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations

GB(1)