The BASA Study: Breath Analysis for Severe Asthma Patients

NCT05946421 | Unknown

• 1 other identifier: Università di Palermo
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Asthma

Keywords

severe asthma; exhaled breath; biologics; monitoring

Outcome Measures

Primary Outcomes (1)

• evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy

  16 weeks

Secondary Outcomes (1)

• evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients

  16 weeks

Other Outcomes (1)

• evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics

  16 weeks

Study Arms (2)

Severe Asthma patients on biologics

Device: exhaled breath analysis

Healthy controls

Device: exhaled breath analysis

Interventions

exhaled breath analysis DEVICE

non invasive technology to measure components of exhaled breath

Healthy controls; Severe Asthma patients on biologics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe asthma patients eligible or already on biologic treatment that are able to follow regular visits at 2, 4, 8, 16 weeks, and to perform lung function and exhaled breath analysis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Study Sites (1)

AOUP Policlinico Paolo Giaccone

Palermo, 90100, Italy

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Stefania Principe, PhD

CONTACT

+393478087131; stefaniaprincipe90@gmail.com

Carmen Durante

CONTACT

carmen.durante3@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: July 4, 2023
• Primary Completion: February 4, 2024
• Study Completion: September 4, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

IT (1)