N/A Completed N=50

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

Asthma

Source: ClinicalTrials.gov NCT01648920 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Methacholine Challenge (MCC) Results — 14; 36 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Methacholine Challenge (MCC) Results	14; 36	—
PRIMARY Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results	17.4; 17.7	—
PRIMARY FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb	12; 26	—
PRIMARY FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb	1; 10	—
PRIMARY FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb	1; 0	—
PRIMARY Asthma Diagnosis by MCC Results: Positive MCC Response	11; 3	—
PRIMARY Asthma Diagnosis by MCC Results: Negative MCC Response	0; 36	—
PRIMARY Asthma Diagnosis by FeNO: FeNO <25ppb	10; 28	—
PRIMARY Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb	0; 11	—
PRIMARY Asthma Diagnosis by FeNO: FeNO >50ppb	1; 0	—
PRIMARY Asthma Diagnosis by FeNO: Mean FeNO Value	16.9; 17.8	—
PRIMARY Sensitivity (%) for FeNO	35.7; 57.1; 85.7; 85.7; 85.7; 85.7	—
PRIMARY Specificity (%) for FeNO	75.0; 55.6; 33.3; 25.0; 11.1; 2.8	—
PRIMARY Positive Predictive Value (%) for FeNO	35.7; 33.3; 33.3; 30.8; 27.3; 25.5	—
PRIMARY Negative Predictive Value (%) for FeNO	75.0; 76.9; 85.7; 81.8; 66.7; 33.3	—
PRIMARY FeNO Values by ICS Use: FeNO <25ppb	34; 4	—
PRIMARY FeNO Values by ICS Use: FeNO >= 50ppb	1; 0	—
PRIMARY FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb	10; 1	—
PRIMARY FeNO Values by Smoking Status: FeNO <25ppb	34; 4	—
PRIMARY FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb	11; 0	—
PRIMARY FeNO Values by Smoking Status: FeNO >= 50ppb	0; 1	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01648920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.