The BASA Study: Breath Analysis for Severe Asthma Patients

Recruiting

• Conditions: Severe Asthma

• Registration Number: NCT05946421
• Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Brief Summary

This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-04
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Primary Completion: 2024-02-04
• Study Completion: 2024-09-04

Recruitment & Eligibility

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

Inclusion Criteria

• Severe asthma diagnosis according to the latest recommendation
• Eligible or in treatment with a biologic treatment for severe asthma
• Able to follow istructions
• Able and willing to sign the informed consent

Exclusion Criteria

• Not able to perform lung function measurements and the procedures of the study
• Acute respiratory or non respiratory infection (<4 weeks)
• Not willing to continue the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy	16 weeks

Secondary Outcome Measures

Name	Time	Method
evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients	16 weeks

Trial Locations

Locations (1)

AOUP Policlinico Paolo Giaccone; 🇮🇹 Palermo, Italy