The BASA Study: Breath Analysis for Severe Asthma Patients

NCT ID: NCT05946421

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2024-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe Asthma patients on biologics

exhaled breath analysis

Intervention Type DEVICE

non invasive technology to measure components of exhaled breath

Healthy controls

exhaled breath analysis

Intervention Type DEVICE

non invasive technology to measure components of exhaled breath

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exhaled breath analysis

non invasive technology to measure components of exhaled breath

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stefania Principe

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AOUP Policlinico Paolo Giaccone

Palermo, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stefania Principe, PhD

Role: CONTACT

+393478087131

Carmen Durante

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Carmen Durante

Role: primary

Nicola Scichilone, Prof

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Università di Palermo

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomarkers in Dyspnea
NCT03056547 COMPLETED NA