The BASA Study: Breath Analysis for Severe Asthma Patients

July 13, 2023 updated by: Stefania Principe, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Palermo, Italy, 90100
        • Recruiting
        • AOUP Policlinico Paolo Giaccone
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefania Principe, PhD
        • Principal Investigator:
          • Nicola Scichilone, Prof
        • Sub-Investigator:
          • Alida Benfante, MD
        • Sub-Investigator:
          • Carmen Durante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients
Time Frame: 16 weeks
16 weeks

Other Outcome Measures

Outcome Measure
Time Frame
evaluate whether there are specific exhaled biomarkers useful to monitor patients with severe asthma on long-term treatment with biologics
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

February 4, 2024

Study Completion (Estimated)

September 4, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Università di Palermo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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