Breath analysis for patients with severe asthma
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
This study is testing how biologic treatments change breath markers in people with severe asthma to see how they affect lung function and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Academic / other |
| Locations | 1 site (Palermo) |
| Trial ID | NCT05946421 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the fluctuations of exhaled breath markers in patients with severe asthma who are receiving biologic treatments. Participants will be monitored for up to 16 weeks to assess lung function and inflammation using non-invasive technologies such as exhaled breath analysis. A control group will be followed for up to two weeks to compare the modifications of inflammation markers. The goal is to identify how biologic treatments affect these markers in severe asthma patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with severe asthma who are eligible for or currently receiving biologic treatment.
Not a fit: Patients who cannot perform lung function measurements or have acute infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of severe asthma through non-invasive breath analysis.
How similar studies have performed: Other studies have shown promise in using breath analysis for monitoring asthma, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palermo
- AOUP Policlinico Paolo Giaccone — Palermo, Italy (Recruiting)
Study contacts
- Study coordinator: Stefania Principe, PhD
- Email: stefaniaprincipe90@gmail.com
- Phone: +393478087131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.