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

Detailed Summary

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.

Study Details

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Interventions