Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- FeNO Values by ACT Score
研究概览
简要总结
Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.
Secondary objectives: Evaluate the ability of physicians to correctly assess airway inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement). Estimate the cost consequences of changes in asthma management following FeNO determinations
Number of participants: Approximately 40 to 50 subjects will participate in the study during an (approximately) 8-12 week study enrollment period.
Reference product: NIOX MINO® Instrument (09-1100)
Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).
Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4) FeNO has been measured and seen by the Physician/Health Care Practitioner.
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 (CIP) from the time that informed consent has been provided and during the study period
Criteria for evaluation: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may be used to design subsequent studies in subjects with asthma. Data collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing
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. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway diseases such as asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Role of Exhaled Nitric Oxide (FeNO):
FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part of the inflammatory process.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 7 to 60 years of age, inclusive
- •Sex: Males and Females
- •Diagnosis: Asthma
排除标准
- •Concurrent Conditions or Disease: Subjects with an established diagnosis of chronic, obstructive pulmonary disease (COPD) cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, or vocal cord dysfunction are excluded from participation
- •Cigarette Smoking: Subjects with greater than a 10 pack-year history of cigarette smoking are excluded from participation
- •Study Participation Outside of This Protocol: Subjects 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 from participation
结局指标
主要结局
FeNO Values by ACT Score
时间窗: Study Visit (single visit study). Approximately 1 hour.
Scores on an asthma control test (ACT) of \<=19 indicates less well controlled asthma, scores \>19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.
FeNO Categorical Levels by ICS Use
时间窗: Study visit (single visit study). Approximately1 hour.
Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (\<25 ppb), intermediate (\>=25 to \<=50 ppb) and high (\>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.
次要结局
- Physician Assessment of Airway Inflammation(Study visit (single visit study) approximately 1 hour)
- Number of Participants Correctly Categorized by True Level of Airway Inflammation(Study visit (single visit study) approximately 1 hour.)
- Asthma Management Changes After FeNO Results Were Considered(Study visit (single visit study). Approximately1 hour.)