Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.

      Measuring the amount of FeNO is useful in the initial assessment of patients with chronic
      cough or non-specific respiratory symptoms suggestive of asthma, and for the management of
      patients with established asthma who are receiving corticosteroid treatment.

      Intended Use:

      NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased
      in inflammatory processes such as asthma. The fractional NO concentration in expired breath
      (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and
      according to guidelines for NO measurement established by the American Thoracic Society.

      Rationale for Study:

      None of the standard clinical assessment tools provide information regarding underlying
      airway inflammation, the control of which is central to an effective asthma management
      strategy. Therefore this study will evaluate the impact of FeNO assessments on asthma
      treatment decisions in approximately 40-50 subjects 7-60 years of age with asthma. This pilot
      study will also provide information regarding the ability of physicians to correctly assess
      airway inflammation using standard clinical assessment tools (i.e., prior to FeNO
      measurement). Finally, this pilot study will allow the cost consequences of changes in asthma
      management following FeNO determinations to be estimated.

      CLINICAL INVESTIGATION OBJECTIVES The primary objective of this study is to evaluate the
      impact of FeNO assessments on asthma treatment decisions.

      The secondary objectives of this study are to:

        -  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.

      CLINICAL INVESTIGATION PLAN

      This is a pilot, observational, single-center, single-visit, outpatient study. Approximately
      30 to 50 subjects will participate in the study during an (approximately) 8 to 12 week study
      enrollment period. Eligible subjects who meet the inclusion/exclusion criteria for this study
      will be invited to participate. The following documentation and information will be provided
      by subjects:

        -  Informed consent

        -  Demographics

        -  Smoking history (cigarettes only)

        -  Usual asthma standard of care assessments

        -  Asthma control test questionnaire

        -  Spirometry

        -  Study physician questions

      FeNO: FeNO will be performed and the value will be reviewed and record.

      Subject discharge from the study:

      Once all information has been collected and all procedures have been performed, the subject
      will be discharged from the clinic and their study participation will be complete

      Medical device:

      The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device
      for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation.
      The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which
      will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in
      adults 18 years of age or older in the initial assessment and management of asthma.

      The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow
      rate. Results are provided at the point of care within 2 minutes after the successful
      completion of the breath test. The test cannot be influenced by patient effort or variations
      in the clinician's test technique.

      Definitions:

      Adverse event: Any incident where the use of a medical device (including in vitro
      diagnostics) is suspected to have resulted in an adverse outcome in a patient.

      Serious Injury means injury or illness that:

        -  Is life-threatening

        -  Results in permanent impairment of a body function or permanent damage to a body
           structure, or

        -  Necessitates medical or surgical intervention to preclude permanent impairment of a body
           function or permanent damage to a body structure.

      Malfunction: the failure of a device to meet its performance specifications or otherwise
      perform as intended.

      Caused or contributed: the death or serious injury was or may have been attributed to a
      medical device, or that the medical device was or may have been a factor in a death or
      serious injury, including events occurring as a result of:

        -  Failure

        -  Malfunction

        -  Improper or inadequate design

        -  Manufacture

        -  Labeling

        -  User error
    

Intervention name(s): NIOX MINO® Instrument (09-1100)
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects, 7 to 60 years of age, inclusive, with asthma will be recruited
      
Keywords: Asthma