Brief 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

June 1, 2012

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed

20 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

April 9, 2014

Completed

Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

July 5, 2012

Results QC Date

November 27, 2013

Last Update Submit

April 8, 2014

Conditions

Asthma

Keywords

AsthmaSuspected but undiagnosed asthma

Outcome Measures

Primary Outcomes (21)

Methacholine Challenge (MCC) Results
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). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results
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). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb
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). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline.
approximately 1-hour
FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb
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). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline.
approximately 1-hour
FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb
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). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline.
approximately 1-hour
Asthma Diagnosis by MCC Results: Positive MCC Response
Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine.
approximately 1-hour
Asthma Diagnosis by MCC Results: Negative MCC Response
Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline.
approximately 1-hour
Asthma Diagnosis by FeNO: FeNO <25ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
Asthma Diagnosis by FeNO: FeNO >50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
Asthma Diagnosis by FeNO: Mean FeNO Value
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
approximately 1-hour
Sensitivity (%) for FeNO
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Sensitivity is a way of saying how likely a test is positive if you have a disease and is expressed as (%) percent. For this study, sensitivity was the ability of FeNO to correctly identify a study participant who has asthma.
approximately 1-hour
Specificity (%) for FeNO
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Specificity is a way of saying how likely a test is negative if you do not have a disease and is expressed as (%) percent. For this study, specificity was the ability of FeNO to correctly identify a study participant who does not have asthma.
approximately 1-hour
Positive Predictive Value (%) for FeNO
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Positive predictive value is a way of saying the likelihood a positive test means you have a disease. In this study, it is defined as the percentage of study participants with a high FeNO who have asthma.
approximately 1-hour
Negative Predictive Value (%) for FeNO
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Negative predictive value is a way of saying the likelihood of a negative test means you do not have disease. In this study it is defined as the percentage of study participants with a low FeNO who do not have asthma.
approximately 1-hour
FeNO Values by ICS Use: FeNO <25ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \<25ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids.
approximately 1-hour
FeNO Values by ICS Use: FeNO >= 50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \>=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids.
approximately 1-hour
FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \<=25ppb to \<=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids.
approximately 1-hour
FeNO Values by Smoking Status: FeNO <25ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \<25ppb who either did not smoke previously or are current smokers.
approximately 1-hour
FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \>=25ppb to \<=50ppb who either did not smoke previously or are current smokers.
approximately 1-hour
FeNO Values by Smoking Status: FeNO >= 50ppb
Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO \>=50ppb who either did not smoke previously or are current smokers.
approximately 1-hour

Study Arms (1)

FeNO

Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests

Device: NIOX MINO® Instrument (09-1100)

Interventions

NIOX MINO® Instrument (09-1100)DEVICE

The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate.

FeNO

Eligibility Criteria

Age7 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

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

Contact the study team to confirm eligibility.