Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age

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

Inclusion criteria

• Age: 7 to 60 years of age, inclusive
• Sex: Males and Females
• Diagnosis: Asthma

Exclusion criteria

• 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