PROPULSION SANTE: Inflammometry to Improve the Diagnostic Trajectory in Situations of Suspected Asthma in Children and Adults

NCT06981169 | Recruiting

• 1 other identifier: MP-31-2025-5593
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this observational study is to assess the relevance of inflammometry (based on the measurement of fractional exhaled nitric oxide (FeNO) and blood eosinophil count (BEC)) as a tool for prioritizing respiratory diagnostic tests. The study will evaluate the role of inflammometry (FeNO and BEC) in prioritizing diagnostic respiratory tests. It will include patients aged six and older with suspected asthma, referred by non-pulmonologists for diagnostic asthma testing (spirometry or methacholine challenge test) at three hospital centers: Sherbrooke University Hospital Center (CHUS), Sainte-Justine University Hospital Center (CHU Sainte-Justine), and the Montreal Children's Hospital. The hypothesis is that using inflammometry as a prioritization tool would reduce diagnostic delays for high-risk patients with elevated biomarkers. This study could help shorten wait times, relieve congestion in diagnostic testing queues, and improve the diagnostic pathway. Additionally, it would enhance the interpretation of pulmonary function test results by incorporating inflammometry findings, leading to better patient stratification. Patients referred from primary care will undergo pulmonary function testing (spirometry ± methacholine challenge) and, as part of the study: FeNO measurement using a portable device Blood test for eosinophil count Questionnaire on asthma control and quality of life, completed at the visit and at follow-ups at 4, 8, and 12 months

Conditions

Asthma; Inflammation; Asthma in Children

Keywords

Diagnosis; Asthma; inflammation; FeNO; Blood eosinophil count

Outcome Measures

Primary Outcomes (1)

• Comparison of the diagnostic delay for asthma in patients with high risk due to elevated inflammatory markers versus those with low risk

  The average delay before the implementation of the project will be calculated based on 25 methacholine challenge tests requested by primary care and performed before the project.The average time during implementation will be analyzed continuously, both overall and in subgroups based on inflammatory status.

  At the time of the methacholine challenge test

Secondary Outcomes (7)

• Impact of inflammatory status on quality of life according astshma control before and after diagnostic testing

  at the baseline, then 4, 8, 12 month

• Diagnostic performance of fractional exhaled nitric oxide (FeNO)

  At the time of the methacholine challenge test

• Diagnostic performance of Blood eosinophils count

  At the time of the methacholine challenge test

• Comparison of the Economic Efficiency of Asthma Diagnostic Algorithms

  baseline visit up to 12 months after the diagnostic tests

• Analysis of user satisfaction questionnary regarding inflammometry

  baseline visit

Study Arms (1)

Patients aged ≥6 years awaiting respiratory function tests requested by primary care

People aged ≥6 years waiting for their respiratory test will be invited to a clinical appointment and offered additional evaluation as part of this study, including : 1/ medical history 2/ exhaled fraction of nitric oxide FeNO measurement (using a portable NIOX VERO device) 3/ a blood test to measure blood eosinophil count (BEC) 4/Questionnaires to be completed on quality of life and asthma control, as well as satisfaction forms.

Diagnostic Test: FeNO; Diagnostic Test: blood sample

Interventions

FeNO DIAGNOSTIC_TEST

FeNO measured with a NIOX VERO device before the respiratory test

Patients aged ≥6 years awaiting respiratory function tests requested by primary care

blood sample DIAGNOSTIC_TEST

Blood sample for measuring the blood eosinophil count

Patients aged ≥6 years awaiting respiratory function tests requested by primary care

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with asthma-suggestive symptoms, referred to Sherbrooke Universty Hospital Center (CHU), CHU Sainte-Justine, and the Montreal Children's Hospital by a non-pulmonologist healthcare professional for asthma diagnosis (pre/post-bronchodilator spirometry and, if non-diagnostic, a methacholine bronchial provocation), will be scheduled for an appointment with the project's designated respiratory therapist .

You may qualify if:

• patients age 6 and older
• referred by primary care ofr an asthma diagnostic test (spirometry or methacholine challenge)

You may not qualify if:

• referred by pulmonologist

Sponsors & Collaborators

• Université de Sherbrooke: lead
• AstraZeneca: collaborator
• Niox Group Plc: collaborator
• Ministere de la Sante et des Services Sociaux: collaborator
• Association Pulmonaire du Quebec: collaborator
• Fonds recherche du Québec Santé: collaborator

Study Sites (3)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Quebec, H4A 3H9, Canada

NOT YET RECRUITING

CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Related Publications (1)

• Gronnier 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.

  PMID: 41314665 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, urine, nasal epithelial lining fluid

MeSH Terms

Conditions

Asthma; Inflammation; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Simon Couillard, MD, MSc

CONTACT

+1-819-346-1110; s.couillard@usherbrooke.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 20, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: up to 2035
• Access Criteria: Data of this study may be shared if the investigators proposed use of the data has been approved by the study principal investigator and an institutional research ethics committee.

Locations

CA (3)