NCT05946421RecruitingNot Applicable
The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo1 site in 1 country100 target enrollmentStarted: July 4, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
Time Frame: 16 weeks
Secondary Outcomes
- evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients(16 weeks)
Investigators
Stefania Principe
MD, PhD
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Study Sites (1)
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