An Observational, Multi-Center, Single-Visit Study to Assess the Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 13
- 主要终点
- Relationship Between FeNO and the Diagnosis of Asthma
研究概览
简要总结
Overall Aim:
To better understand the diagnostic process for prolonged respiratory events and determine the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology.
Study Objectives:
The specific objectives of this study are to:
- Determine the frequency of ICS prescription for the treatment of non-specific lower respiratory symptoms.
- Determine the frequency of asthma diagnosis as an etiology for the non-specific lower respiratory symptoms.
- Explore the value of FeNO in identifying asthma as the etiology of the non-specific lower respiratory symptoms.
Number of Subjects:
It is anticipated that up to approximately 3,000 patients will be asked to complete the brief screening questionnaire that will be used to identify up to approximately 280 eligible patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6 week study enrollment period.
Reference Product: NIOX MINO®
Duration of the participants involvement in the investigation: Single Visit
Performance assessments:
Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO® device according to "Instructions for NO measurements" which will be provided to each Investigative site prior to patient enrollment.
Safety Assessments:
The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time of informed consent/assent and during the study period.
Criteria for Evaluation:
The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS will be explored by correlation, measures of concordance and logistic modeling.
详细描述
INTRODUCTION:
Overview:
The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical practice at the point-of-care. Airway inflammation is now recognized as the central mechanism in the pathogenesis of asthma and its symptoms. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Burden of Disease:
The burden of asthma in the U.S. is significant and growing. In May 2011, the Centers for Disease Control and Prevention (CDC) reported that the prevalence of asthma has increased by 12.3% from 2001 to 2009 and affects approximately 24.6 million Americans, including 9.6% of the pediatric population. In 2008, at least one half (52.6%) of persons with asthma in the U.S. reported having an asthma attack in the preceding 12 months. In 2007, there were 1.75 million asthma-related emergency department visits and 456,000 asthma hospitalizations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms: Must have non-specific lower respiratory symptoms, such as cough, wheeze, and/or shortness of breath
- •Age: Seven (7) to 65 years, inclusive
- •Sex: Males and Females
- •Ability to successfully perform assessment of FeNO: Investigators should use their judgment to determine if study candidates will be able to successfully perform assessment of FeNO using the NIOX MINO®.
排除标准
- •Diagnosis: No previous or current diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
- •Medications: No use of inhaled or oral corticosteroids within 7 days prior to the visit.
- •Study Participation Outside of This Protocol: Patients currently enrolled in studies of Investigational or non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded.
结局指标
主要结局
Relationship Between FeNO and the Diagnosis of Asthma
时间窗: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)
For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and \>35 ppb is high. For those aged 12 years or older, \<25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and \>50 ppb is high.
Relationship Between FeNO and the Prescription of ICS in Primary Care Practices
时间窗: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)
The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and \>35 ppb is high. For those aged 12 years or older, \<25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and \>50 ppb is high.
次要结局
- Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study(anytime prior to the single study visit)