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
patients age 6 and older
referred by primary care ofr an asthma diagnostic test (spirometry or methacholine challenge)
referred by pulmonologist
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 .
Cohort
Prospective
FeNO
Diagnostic testFeNO measured with a NIOX VERO device before the respiratory test
blood sample
Diagnostic testBlood sample for measuring the blood eosinophil count
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.
Impact of inflammatory status on quality of life according astshma control before and after diagnostic testing
Comparison of Asthma Control Questionnaire
Diagnostic performance of fractional exhaled nitric oxide (FeNO)
ROC curve analysis of FeNO values. The diagnosis of asthma will be confirmed by a positive methacholine challenge with a dose provocation (DP20) \<400 mcg (equivalent of concentration provocation (CP20) \<16 mg/mL). An exploratory analysis following European standards (DP20 ≤ 200 mcg or CP20 ≤ 8 mg/mL28-30) will also be conducted.
Diagnostic performance of Blood eosinophils count
ROC curve analysis of BEC values. The diagnosis of asthma will be confirmed by a positive methacholine challenge with a DP20 \<400 mcg (CP20 \<16 mg/mL). An exploratory analysis following European standards (DP20 ≤ 200 mcg or CP20 ≤ 8 mg/mL28-30) will also be conducted.
Comparison of the Economic Efficiency of Asthma Diagnostic Algorithms
Sum of health expenses attributable to asthma for the participant in Canadian dollar, including medication, hospitalization, estimation
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Université de Sherbrooke
Lead sponsor
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
