A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma

Male and female subjects, approximately 7 years of age and above with suspected but undiagnosed asthma that are scheduled to undergo Methacholine Challenge (MCC) testing as part of the routine evaluation of suspected asthma.

Inclusion Criteria:

• Subjects with suspected but undiagnosed asthma that are scheduled to undergo MCC testing as part of the routine evaluation of suspected asthma.

Exclusion Criteria:

• Concurrent Conditions or Disease:
• current diagnosis of asthma, COPD, or other chronic respiratory disease
• upper or lower respiratory infection (including the common cold) that has not resolved within 4 weeks prior to the MCC test

Medication Use:

• scheduled use of asthma and allergy medication(s) should be discontinued at least 48 hours prior to MCC testing
• rescue medications should be discontinued at least 8 hour prior to MCC testing

Smoking:

- smoking should be avoided for at least 8 hours prior to MCC testing

Exercise:

- exercise or outdoor activity should be avoided for at least 2 hours prior to testing

Vaccinations:

-vaccinations should be avoided at least 2 weeks prior to MCC testing

Study participation outside of the 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