The BASA Study: Breath Analysis for Severe Asthma Patients | NCT05946421

Studies
The BASA Study: Breath Analysis for Severe Asthma Patients

NCT05946421

Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Status

Unknown status

Last Update Posted

Jul 14, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Severe Asthma

Interventions

exhaled breath analysis

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2023Actual

Primary Completion Date

Feb 4, 2024Estimated

Completion Date

Sep 4, 2024Estimated

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefania Principe, MD, PhD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe Asthma patients on biologics			Device: exhaled breath analysis
Healthy controls			Device: exhaled breath analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exhaled breath analysis	Device	non invasive technology to measure components of exhaled breath	Healthy controls Severe Asthma patients on biologics

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefania Principe, PhD	Contact	+393478087131		stefaniaprincipe90@gmail.com
Carmen Durante	Contact			carmen.durante3@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOUP Policlinico Paolo Giaccone	Recruiting	Palermo		90100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided