The BASA Study: Breath Analysis for Severe Asthma Patients

• Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05946421
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 14.1
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Asthma	Device: exhaled breath analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jul 4, 2023
• Anticipated Primary Completion Date: Feb 4, 2024
• Anticipated Study Completion Date: Sep 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Severe Asthma patients on biologics	Device: exhaled breath analysis; non invasive technology to measure components of exhaled breath
Healthy controls	Device: exhaled breath analysis; non invasive technology to measure components of exhaled breath

Outcome Measures

Primary Outcome Measures

1. evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy [16 weeks]

Secondary Outcome Measures

1. evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients [16 weeks]

Other Outcome Measures

1. evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOUP Policlinico Paolo Giaccone	Palermo		Italy	90100

Sponsors and Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefania Principe, MD, PhD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
• ClinicalTrials.gov Identifier: NCT05946421
• Other Study ID Numbers: Università di Palermo
• First Posted: Jul 14, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefania Principe, MD, PhD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: severe asthma; exhaled breath; biologics; monitoring
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Jul 14, 2023