The BASA Study: Breath Analysis for Severe Asthma Patients

Severe Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946421
• Other study ID #: Università di Palermo
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: September 4, 2024

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
• Contact: Stefania Principe, PhD
• Phone: +393478087131
• Email: stefaniaprincipe90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 4, 2024
• Est. primary completion date: February 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Device:
• exhaled breath analysis
non invasive technology to measure components of exhaled breath

Locations

Country	Name	City	State
Italy	AOUP Policlinico Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics		16 weeks
Primary	evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy		16 weeks
Secondary	evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients		16 weeks