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

Completed

Conditions studied: Asthma

In brief

Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed asthma Number of participants: Approximately 50 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual. MCC testing will be performed according to the ATS guidelines and the allergy and asthma specialists procedure for conducting MCC tests 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 that informed consent has been provided and during the study period Criteria for evaluations: This is an exploratory study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design and power subsequent studies in patients with suspected but undiagnosed asthma. Information collected will be summarized in a clinical study report

Key facts

Study ID

NCT01648920

Run by

Aerocrine AB

People needed

50

Starts

2012-06-01

Expected to finish

2012-11-01

Last updated by the study team

2014-04-09

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Allergy and Asthma Specialists, PC — Blue Bell, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Collegeville, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Doylestown, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Jenkintown, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — King of Prussia, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Lansdale, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Philadelphia, Pennsylvania, United States
• Allergy and Asthma Specialists, PC — Pottsville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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