PROPULSION SANTE: Inflammometry to Improve the Diagnostic Trajectory in Situations of Suspected Asthma in Children and Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Comparison of the diagnostic delay for asthma in patients with high risk due to elevated inflammatory markers versus those with low risk
研究概览
简要总结
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
详细描述
BACKROUND : Asthma is one of the most prevalent chronic diseases worldwide. In Canada, it affects 11% of the population. In Quebec, an estimated 900,000 people suffer from asthma, including 300,000 children. Type 2 eosinophilic inflammation is present in 50% of asthma cases and in 95% of individuals with severe disease, who consume more healthcare resources. This type of inflammation is clinically identified through non-invasive measurements of exhaled nitric oxide (FeNO) and blood eosinophil count (BEC).
Asthmatic patients with Type 2 inflammation are at higher risk of asthma attacks and appear to be at risk of accelerated lung function decline, both in adults and children. The presence of Type 2 inflammation predicts a strong response to inhaled corticosteroids (ICS).
Currently, post-bronchodilator reversibility and/or bronchial hyperresponsiveness documented via spirometry are the two main approved methods for diagnosing asthma. Bronchial provocation testing is required in 80% of suspected asthma cases, but our population faces a severe lack of access to this test.The average wait time for this 1-2 hour procedure exceeds one year in our three centers.
Currently, prioritization is based on the order in which requests are received, with internal referrals given priority over external ones. In Europe, FeNO is already used as a complementary diagnostic tool in primary care, while in Quebec, it is only accessible in severe asthma clinics.
Type 2 eosinophilic inflammation is present in 50% of asthma cases and in 95% of severe asthma cases. This inflammation can be identified through non-invasive biomarkers, such as FeNO and blood eosinophil count. Individuals with type 2 inflammation are at higher risk for asthma attacks and are more likely to experience accelerated decline in respiratory function, both in adults and children. However, type 2 inflammation also predicts a strong response to inhaled corticosteroids (ICS).The identification of these markers represents a treatable trait.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients age 6 and older
- •referred by primary care ofr an asthma diagnostic test (spirometry or methacholine challenge)
排除标准
- •referred by pulmonologist
结局指标
主要结局
Comparison of the diagnostic delay for asthma in patients with high risk due to elevated inflammatory markers versus those with low risk
时间窗: At the time of the methacholine challenge test
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.
次要结局
- 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)
- Evaluation of the environmental impact(baseline visit up to 12 months after the diagnostics tests)
- Evaluation of asthma control according to medication use(At the time of the initial visit, then at the 4, 8 and 12-month follow-up questionnaires)