Severe AsthmaNCT05946421
The BASA Study: Breath Analysis for Severe Asthma Patients
An observational study of Severe Asthma, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Asthma
- What is being tested?
- exhaled breath analysis
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jul 2023to 4 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Carmen Durante contact
Italy1 site, 1 recruiting
- Recruiting
AOUP Policlinico Paolo Giaccone
Palermo, 90100
Carmen Durante, carmen.durante3@gmail.com
Nicola Scichilone, Prof, nicola.scichilone@unipa.it
About this study
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
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
- Being tested
- exhaled breath analysis
- Keywords
- severe asthma, exhaled breath, biologics, monitoring
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exhaled breath analysisDevice
non invasive technology to measure components of exhaled breath
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthma patients on biologics | Not described Receives: Device: exhaled breath analysis | |
| Healthy controls | Not described Receives: Device: exhaled breath analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
Measured: 16 weeks
Secondary outcomes (1)
evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start4 Jul 2023
- Primary completion4 Feb 2024 (estimated)
- Study completion4 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania Principe, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946421
- Sponsor's protocol ID
- Università di Palermo
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05946421
- Acronym / sponsor ID
- Università di Palermo
- Conditions
- Severe Asthma
- Keywords
- severe asthma, exhaled breath, biologics, monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 4 Feb 2024 (estimated)
- Study completion
- 4 Sep 2024 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Asthma patients on biologics | – | Device: exhaled breath analysis |
| Healthy controls | – | Device: exhaled breath analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exhaled breath analysisnon invasive technology to measure components of exhaled breath | Device | Healthy controls, Severe Asthma patients on biologics |
Primary outcome
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
Time frame: 16 weeks
1 secondary outcome
evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Durante contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Principe, PhD (+393478087131, stefaniaprincipe90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.