AsthmaDIVENCT05992519
Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma
An observational study of Asthma and Asthma in Children, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Asthma is characterised by episodic symptoms (attacks) caused by airway inflammation and decreased airflow to the lungs. It affects 10% of the Canadian population and is the most common chronic disease in childhood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Asthma in Children, Diagnosis
- What is being tested?
- ¸FeNO
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2022to 31 Oct 2025
- 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
- Adult, Older adult
Study population: The study has a collaboration agreement with the respiratory physiology service. In this context, a research invitation letter will be sent with confirmation of the appointment. The letter indicates that participation is voluntary and provides the expected length of the appointment (20-30 minutes), a QR code referring them to an online version of the Information and Consent Form (ICF), and a cell phone number and email address for the research team, with a phone number for individuals to state their refusal to be contacted. In the week preceeding the challenge, the clinical inhalation therapist will call non-objecting pre-screened patients to discuss the project and plan the study visit.
Who may be able to join
- aged ≥ 12 years who have symptoms suggestive of asthma,
- referred by their primary care provider (defined as a non-respirologist, non-allergist, non-otolaryngologist) using the CHUS suspected asthma decision-making algorithm. Under that algorithm, patients have non-diagnostic pre- and post-bronchodilator spirometry and no contraindications to a methacholine challenge.
- Free and informed consent must be given by the patient (and their legal guardian, if applicable).
Who cannot join
- Use of an inhaled or systemic corticosteroid in the previous 48 hours;
- Smoking in the previous 6 hours; history of viral and/or bacterial respiratory infection in the past 4 weeks;
- major cardiopulmonary disease, including: a) chronic obstructive pulmonary disease (COPD), defined by all of the following: i) aged ≥ 40 years , ii) permanent obstruction on spirometry (FEV1/FVC <0.7) and iii) a smoking history of >10 pack-years or known alpha-1-antitrypsin deficiency, b) lung conditions deemed significant by the investigator, including cystic fibrosis and bronchiectasis, and c) unstable heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma (DIVE)
Asthma is characterised by episodic symptoms (attacks) caused by airway inflammation and decreased airflow to the lungs. It affects 10% of the Canadian population and is the most common chronic disease in childhood. Despite its burden and its potential to be life-threatening, establishing the diagnosis takes time due to difficulty in accessing specialised breathing tests. Indeed, the current diagnostic strategy relies on a breathing test (spirometry) and, if non-diagnostic, a subsequent more complicated breathing test conducted in hospitals (a bronchial provocation test). Our dependence on the latter test must be confronted to the bottleneck created by our reliance on it and the difficulty to do these tests in children. Furthermore, within the current framework, people receiving a diagnosis do not know if they have active airway inflammation - a key feature with predicts increased susceptibility to asthma attacks and treatment responsiveness.
Our study's goal is to validate clinically accessible and useful diagnostic tests for peoplesuspected to have asthma. Specifically, we are interested in alternative tests that are a) achievable outside the hospital; b) useful markers of airway inflammation/risk c) can identify people at with a higher likelihood of responding to anti-inflammatory therapy. The two tests we are mainly interested in are:
- Exhaled nitric oxide (measured with a portable handheld machine)
- The blood eosinophil count (obtained on a general blood test) +/- Other tests which we might be able to develop within this cohort (e.g. urine tests)
Read the detailed description
BACKGROUND Asthma affects 10% of the general population but remains a diagnostic challenge. Considering the difficult access, weak specificity, and low clinical utility of bronchial provocation tests, more effective diagnostic methods are needed. Blood eosinophils and exhaled nitric oxide (FeNO) are biomarkers of type-2 inflammation that have established mechanistic, prognostic and theragnostic values in chronic asthma. Specifically, these biomarkers identify attack-prone patients with ongoing alarmin, type-2 cytokine, and chemokine signalling at the epithelial level driving airway hyperresponsiveness and accelerated lung function decline. Most importantly, these biomarkers also identify those who benefit the most from anti-inflammatory therapy. Considering the above clinical utilities, using biomarkers in primary care to diagnose airways disease in people with suspected asthma would represent a very effective diagnostic strategy.
HYPOTHESIS: In people with non-diagnostic spirometry and asthma suspected by primary care, measuring blood eosinophils and FeNO is a feasible diagnostic strategy with good accuracy and the added value of early mechanistic insight in epithelial signalling pathways.
OBJECTIVE: To estimate the diagnostic performance parameters of type-2 biomarkers in people with suspected asthma and a non-diagnostic spirometry. An exploratory analysis of inflammatory proteins (alarmin, type-2 cytokines, chemokines) in the nasal epithelial lining fluid (NELF) and serum according to biomarkers will be conducted. This and other secondary exploratory objectives will lead to better mechanistic and operational insight on the value of type-2 biomarkers in early disease.
METHODS: The investigators propose a prospective observational study on the logistical feasibility, receiver operating characteristics (ROC), and mechanistic value of point-of-care type-2 inflammatory biomarkers to diagnose asthma (Figure). The study will include 123 people ≥18 years old with non-diagnostic pre-postbronchodilator spirometry referred by primary care for a methacholine challenge via the Suspected Asthma pathway of the Centre Hospitalier Universitaire de Sherbrooke. After the methacholine challenge, patients will complete questionnaires, have blood eosinophils measured (by venous blood sample), FeNO measured (by electroluminescence), nasosorption performed, and serum harvested for allergy testing and inflammatory protein measurement.
OUTCOMES: The main analysis will be ROC plots of (1) FeNO alone; (2) blood eosinophils alone; and (3) the combination of blood eosinophils and FeNO;. The ROC plot will be based on a methacholine provocative dose ≤200 mcg (~ provocative concentration ≤8 mg/mL). The target sample size of 123 will have 90% power to compute 3 ROC curves' area under the curve (AUC) ≥ 0.7 significantly different from the null hypothesis (AUC=0.5) with a conservatively corrected two-sided α error < 0.016, assuming a positive/negative case ratio of 2. Secondary outcomes are the diagnostic and cost-effectiveness of blood eosinophil and FeNO measurement compared to methacholine challenges; and univariate plus multivariate modelling between blood eosinophils, FeNO, and inflammatory proteins (alarmins TSLP and IL-33; type-2 cytokines IL-4, -5, -13; chemokines eotaxin-3 and TARC) measured in the NELF and serum, or metabolites measured in the urine.
EXPECTED RESULTS: It is expected that type-2 inflammometry to be a useful alternative diagnostic pathway with benefits extending beyond diagnostic accuracy thanks to early insight into the inflammatory phenotype.
IMPACT: This observational study will support further validation studies and/or trials assessing biomarker-assisted diagnosis and management of asthma in the community setting. Measuring biomarkers at the time of diagnosis could facilitate a 'predict and prevent' approach to diagnostic algorithms in airway disease
- Conditions
- Asthma, Asthma in Children, Diagnosis, Inflammation
- Being tested
- ¸FeNO
- Medical subject headings
- Asthma, Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¸FeNODiagnostic test
FeNO measured with a NIOX VERO device after the methacholine challenge
| Study group | Role | What they receive |
|---|---|---|
| People suspected with asthma | Patients will receive an in invitation letter at the time of BPT scheduling. In the week proceeding the test, the clinical inhalation therapist will discuss the project and schedule the study visit on the day of the BPT. The study visit will be done prior to BPT whenever possible.
Baseline visit:
* Medical history
* 5-item Asthma Control Questionnaire (ACQ-5)
* FeNO measurement (NIOX VERO device)
* Nasosorption for nasal epithelial lining fluid (NELF) biobanking
* blood tests (complete blood count with differential, C-reactive protein, total and specific serum immunoglobulin E, biobank)
* urine sample (biobank) Receives: Diagnostic Test: ¸FeNO |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of the ROC analysis to diagnose asthma
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
Measured: FeNO measured on the day of the methacholine challenge (i.e. Baseline visit)
Blood eosinophil count: ROC analysis AUC to diagnose asthma
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
Measured: Blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit)
Combination of FeNO + Blood eosinophil count: ROC analysis AUC to diagnose asthma
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
Measured: FeNO and blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit)
Secondary outcomes (3)
Univariate association between biomarkers (blood eosinophils and FeNO) and inflammatory proteins/metabolites
Inflammatory proteins/metabolites measured in the NELF, serum, and urine. Further exploratory multivariate modelling adjusting for atopy (defined as a history of eczema, rhinoconjunctivitis, or food allergy and/or at least one sensitisation to an airbourne sensitiser) and biological sex.
Measured: Baseline
Operational efficacy of the use of biomarkers as a diagnostic tool:
- Potential reduction in diagnostic delay in asthma patients: the difference (in days) between the date of the challenge test and the date of the request
- Time difference (in minutes/days) for diagnosing asthma using biomarkers (FeNO + eosinophilia) versus a methacholine challenge.
- Cost difference between the use of biomarkers (traditional or point-of-care analysed separately) as 2nd diagnosis step versus a standard methacholine challenge test.
Measured: Baseline
Biomarker level in asthmatic patients at time of diagnosis
Expressed as n (%) of diagnosed patients per square in a 3×3 grid stratified by combination of biomarkers (eosinophils <0.15, 0.015-<0.30, ≥0.30×109/L; FeNO <25, 25-<50, ≥50 ppb)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start7 Nov 2022
- Primary completion30 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Association Pulmonaire du Quebec, Réseau de Recherche en Santé Respiratoire du Québec, AstraZeneca, Fonds de la Recherche en Santé du Québec, Fondation JA DeSève
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992519
- Sponsor's protocol ID
- 2023-4791
- Acronym
- DIVE
- Status last verified
- May 2025
- First submitted
- 7 Aug 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gamrani M, Farjallah A, Kpaossou FM, Cliche D, Celis-Preciado C, Gronnier M, Couillard S, Auray-Blais C. Development and validation of a UHPLC-MS/MS method for the quantification of total conjugated 3-bromotyrosine and investigation of its association with asthma severity. Anal Chim Acta. 2026 Jun 22;1404:345450. doi: 10.1016/j.aca.2026.345450. Epub 2026 Mar 28.
PubMed 41997677Gronnier M, Desy L, Pouliot L, Lemieux SE, Vezina FA, Lachapelle P, Counil FP, Duval M, Cliche D, Lemaire-Paquette S, Coulibaly L, Hudon C, Lands LC, Ducharme FM, Tse S, Couillard S. Integrating blood eosinophils and exhaled nitric oxide (FeNO) in asthma diagnostic pathways for adults and children: the PROPULSION SANTE observational study with translational sub-studies (DIVE, DIVE2)-protocols. BMJ Open Respir Res. 2025 Nov 27;12(1):e003750. doi: 10.1136/bmjresp-2025-003750.
PubMed 41314665
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma (DIVE)
- ClinicalTrials.gov ID
- NCT05992519
- Acronym / sponsor ID
- DIVE / 2023-4791
- Conditions
- Asthma, Asthma in Children, Diagnosis, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Association Pulmonaire du Quebec, Réseau de Recherche en Santé Respiratoire du Québec, AstraZeneca, Fonds de la Recherche en Santé du Québec, Fondation JA DeSève
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 15 Aug 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.
Asthma is characterised by episodic symptoms (attacks) caused by airway inflammation and decreased airflow to the lungs. It affects 10% of the Canadian population and is the most common chronic disease in childhood. Despite its burden and its potential to be life-threatening, establishing the diagnosis takes time due to difficulty in accessing specialised breathing tests. Indeed, the current diagnostic strategy relies on a breathing test (spirometry) and, if non-diagnostic, a subsequent more complicated breathing test conducted in hospitals (a bronchial provocation test). Our dependence on the latter test must be confronted to the bottleneck created by our reliance on it and the difficulty to do these tests in children. Furthermore, within the current framework, people receiving a diagnosis do not know if they have active airway inflammation - a key feature with predicts increased susceptibility to asthma attacks and treatment responsiveness.
Our study's goal is to validate clinically accessible and useful diagnostic tests for peoplesuspected to have asthma. Specifically, we are interested in alternative tests that are a) achievable outside the hospital; b) useful markers of airway inflammation/risk c) can identify people at with a higher likelihood of responding to anti-inflammatory therapy. The two tests we are mainly interested in are:
- Exhaled nitric oxide (measured with a portable handheld machine)
- The blood eosinophil count (obtained on a general blood test) +/- Other tests which we might be able to develop within this cohort (e.g. urine tests)
Detailed description
BACKGROUND Asthma affects 10% of the general population but remains a diagnostic challenge. Considering the difficult access, weak specificity, and low clinical utility of bronchial provocation tests, more effective diagnostic methods are needed. Blood eosinophils and exhaled nitric oxide (FeNO) are biomarkers of type-2 inflammation that have established mechanistic, prognostic and theragnostic values in chronic asthma. Specifically, these biomarkers identify attack-prone patients with ongoing alarmin, type-2 cytokine, and chemokine signalling at the epithelial level driving airway hyperresponsiveness and accelerated lung function decline. Most importantly, these biomarkers also identify those who benefit the most from anti-inflammatory therapy. Considering the above clinical utilities, using biomarkers in primary care to diagnose airways disease in people with suspected asthma would represent a very effective diagnostic strategy.
HYPOTHESIS: In people with non-diagnostic spirometry and asthma suspected by primary care, measuring blood eosinophils and FeNO is a feasible diagnostic strategy with good accuracy and the added value of early mechanistic insight in epithelial signalling pathways.
OBJECTIVE: To estimate the diagnostic performance parameters of type-2 biomarkers in people with suspected asthma and a non-diagnostic spirometry. An exploratory analysis of inflammatory proteins (alarmin, type-2 cytokines, chemokines) in the nasal epithelial lining fluid (NELF) and serum according to biomarkers will be conducted. This and other secondary exploratory objectives will lead to better mechanistic and operational insight on the value of type-2 biomarkers in early disease.
METHODS: The investigators propose a prospective observational study on the logistical feasibility, receiver operating characteristics (ROC), and mechanistic value of point-of-care type-2 inflammatory biomarkers to diagnose asthma (Figure). The study will include 123 people ≥18 years old with non-diagnostic pre-postbronchodilator spirometry referred by primary care for a methacholine challenge via the Suspected Asthma pathway of the Centre Hospitalier Universitaire de Sherbrooke. After the methacholine challenge, patients will complete questionnaires, have blood eosinophils measured (by venous blood sample), FeNO measured (by electroluminescence), nasosorption performed, and serum harvested for allergy testing and inflammatory protein measurement.
OUTCOMES: The main analysis will be ROC plots of (1) FeNO alone; (2) blood eosinophils alone; and (3) the combination of blood eosinophils and FeNO;. The ROC plot will be based on a methacholine provocative dose ≤200 mcg (~ provocative concentration ≤8 mg/mL). The target sample size of 123 will have 90% power to compute 3 ROC curves' area under the curve (AUC) ≥ 0.7 significantly different from the null hypothesis (AUC=0.5) with a conservatively corrected two-sided α error < 0.016, assuming a positive/negative case ratio of 2. Secondary outcomes are the diagnostic and cost-effectiveness of blood eosinophil and FeNO measurement compared to methacholine challenges; and univariate plus multivariate modelling between blood eosinophils, FeNO, and inflammatory proteins (alarmins TSLP and IL-33; type-2 cytokines IL-4, -5, -13; chemokines eotaxin-3 and TARC) measured in the NELF and serum, or metabolites measured in the urine.
EXPECTED RESULTS: It is expected that type-2 inflammometry to be a useful alternative diagnostic pathway with benefits extending beyond diagnostic accuracy thanks to early insight into the inflammatory phenotype.
IMPACT: This observational study will support further validation studies and/or trials assessing biomarker-assisted diagnosis and management of asthma in the community setting. Measuring biomarkers at the time of diagnosis could facilitate a 'predict and prevent' approach to diagnostic algorithms in airway disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People suspected with asthma | – | Diagnostic Test: ¸FeNOPatients will receive an in invitation letter at the time of BPT scheduling. In the week proceeding the test, the clinical inhalation therapist will discuss the project and schedule the study visit on the day of the BPT. The study visit will be done prior to BPT whenever possible. Baseline visit: * Medical history * 5-item Asthma Control Questionnaire (ACQ-5) * FeNO measurement (NIOX VERO device) * Nasosorption for nasal epithelial lining fluid (NELF) biobanking * blood tests (complete blood count with differential, C-reactive protein, total and specific serum immunoglobulin E, biobank) * urine sample (biobank) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study has a collaboration agreement with the respiratory physiology service. In this context, a research invitation letter will be sent with confirmation of the appointment. The letter indicates that participation is voluntary and provides the expected length of the appointment (20-30 minutes), a QR code referring them to an online version of the Information and Consent Form (ICF), and a cell phone number and email address for the research team, with a phone number for individuals to state their refusal to be contacted. In the week preceeding the challenge, the clinical inhalation therapist will call non-objecting pre-screened patients to discuss the project and plan the study visit.
Key inclusion criteria (3 listed)
- aged ≥ 12 years who have symptoms suggestive of asthma,
- referred by their primary care provider (defined as a non-respirologist, non-allergist, non-otolaryngologist) using the CHUS suspected asthma decision-making algorithm. Under that algorithm, patients have non-diagnostic pre- and post-bronchodilator spirometry and no contraindications to a methacholine challenge.
- Free and informed consent must be given by the patient (and their legal guardian, if applicable).
Key exclusion criteria (3 listed)
- Use of an inhaled or systemic corticosteroid in the previous 48 hours;
- Smoking in the previous 6 hours; history of viral and/or bacterial respiratory infection in the past 4 weeks;
- major cardiopulmonary disease, including: a) chronic obstructive pulmonary disease (COPD), defined by all of the following: i) aged ≥ 40 years , ii) permanent obstruction on spirometry (FEV1/FVC <0.7) and iii) a smoking history of >10 pack-years or known alpha-1-antitrypsin deficiency, b) lung conditions deemed significant by the investigator, including cystic fibrosis and bronchiectasis, and c) unstable heart disease.
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 |
|---|---|---|
| ¸FeNOFeNO measured with a NIOX VERO device after the methacholine challenge | Diagnostic test | People suspected with asthma |
Primary outcome
AUC of the ROC analysis to diagnose asthma
Time frame: FeNO measured on the day of the methacholine challenge (i.e. Baseline visit)
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
Blood eosinophil count: ROC analysis AUC to diagnose asthma
Time frame: Blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit)
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
Combination of FeNO + Blood eosinophil count: ROC analysis AUC to diagnose asthma
Time frame: FeNO and blood eosinophils measured on the day of the methacholine challenge (i.e. Baseline visit)
Diagnosis of asthma defined as a methacholine PD20 < 200 mcg
3 secondary outcomes
Univariate association between biomarkers (blood eosinophils and FeNO) and inflammatory proteins/metabolites
Time frame: Baseline
Operational efficacy of the use of biomarkers as a diagnostic tool:
Time frame: Baseline
Biomarker level in asthmatic patients at time of diagnosis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 41997677Gamrani M, Farjallah A, Kpaossou FM, Cliche D, Celis-Preciado C, Gronnier M, Couillard S, Auray-Blais C. Development and validation of a UHPLC-MS/MS method for the quantification of total conjugated 3-bromotyrosine and investigation of its association with asthma severity. Anal Chim Acta. 2026 Jun 22;1404:345450. doi: 10.1016/j.aca.2026.345450. Epub 2026 Mar 28.
- Derived from this study: PubMed 41314665Gronnier M, Desy L, Pouliot L, Lemieux SE, Vezina FA, Lachapelle P, Counil FP, Duval M, Cliche D, Lemaire-Paquette S, Coulibaly L, Hudon C, Lands LC, Ducharme FM, Tse S, Couillard S. Integrating blood eosinophils and exhaled nitric oxide (FeNO) in asthma diagnostic pathways for adults and children: the PROPULSION SANTE observational study with translational sub-studies (DIVE, DIVE2)-protocols. BMJ Open Respir Res. 2025 Nov 27;12(1):e003750. doi: 10.1136/bmjresp-2025-003750.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Asthma and Asthma in Children, run by Université de Sherbrooke at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 19 Nov 2025. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of the ROC analysis to diagnose asthma (time frame: FeNO measured on the day of the methacholine challenge (i.e. Baseline visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992519, which also lists 2 linked publications.
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 19 Nov 2025.