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The BASA Study: Breath Analysis for Severe Asthma Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05946421
Enrollment
100
Registered
2023-07-14
Start date
2023-07-04
Completion date
2024-09-04
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Asthma

Keywords

severe asthma, exhaled breath, biologics, monitoring

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.

Interventions

DEVICEexhaled breath analysis

non invasive technology to measure components of exhaled breath

Sponsors

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy16 weeks

Secondary

MeasureTime frame
evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients16 weeks

Other

MeasureTime frame
evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics16 weeks

Countries

Italy

Contacts

Primary ContactStefania Principe, PhD
stefaniaprincipe90@gmail.com+393478087131
Backup ContactCarmen Durante
carmen.durante3@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026