3TR-ABC multi-scale multiomic analysis of mild/moderate asthma and healthy controls

Not Applicable

• Conditions: Mild/moderate asthma and healthy volunteers; Respiratory

• Registration Number: ISRCTN16417487
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-06
• Last Update Posted: 19 August 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Mild/moderate asthma controls
1. Adult (=18 years old)
2. Diagnosed with mild/moderate controlled asthma:
2.1 Low/medium dose of ICS/LABA +/- LTRA
2.2 ACQ < 1.5
2.3 Markers of T2 inflammation (B-eos = 0.15 actual or = 0.30 the last year or Sputum eos = 3%, FeNO = 25, allergens positivity)
2.4 Markers of T2 low inflammation (B-eos < 0.15 actual or < 0.30 the last year of sputum eos < 3%, FeNO < 25, allergens negativity)
2.5 No exacerbations in the past 12 months
2.6 No need for prednisolone treatment
2.7 Not a direct candidate for biologic therapy
3. Be able to give valid written consent, and compliant with study procedures and study visits.

Healthy controls
1. Adult (=18 years old)
2. Healthy:
2.1 No current medication/therapy for autoimmune, inflammatory, or allergic diseases
2.2 No history of asthma or respiratory symptoms
2.3 No history of allergies
2.4 No upper or lower respiratory infections in the past 4 weeks
3. Be able to give valid written consent, compliant with study procedures and study visits

Exclusion Criteria

Mild/moderate asthma controls
1. Unable to understand written information due to language barriers.
2. Unable to give informed consent, i.e., patients who are incapable.
3. Unable to complete study visits.

Healthy controls
1. Unable to understand written information due to language barriers.
2. Unable to give informed consent, i.e., patients who are incapable.
3. Unable to complete study visits.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Adequacy of asthma control and change in asthma control measured using the Asthma Control Questionnaire 5 Questions (ACQ5) <1.5, assessed at 1 year<br>2. Pulmonary function measured using post-bronchodilator (post-BD) Forced Expiratory Volume in 1 Second (FEV1) percent predicted, at 1 year<br>3. Exacerbations history, assessed using medical history at 1 year<br>4. Oral corticosteroids use, assessed using medical history and current medications at 1 year