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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB
ClinicalTrials.gov Identifier:
NCT01648920
First received: July 5, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Asthma
Device: NIOX MINO® Instrument (09-1100)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Aerocrine AB:

Primary Outcome Measures:
  • Methacholine Challenge (MCC) Results [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by MCC Results: Positive MCC Response [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by MCC Results: Negative MCC Response [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by FeNO: FeNO <25ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by FeNO: FeNO >50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Asthma Diagnosis by FeNO: Mean FeNO Value [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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 (%) for FeNO [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Specificity (%) for FeNO [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Positive Predictive Value (%) for FeNO [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • Negative Predictive Value (%) for FeNO [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by ICS Use: FeNO <25ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by ICS Use: FeNO >= 50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by Smoking Status: FeNO <25ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.

  • FeNO Values by Smoking Status: FeNO >= 50ppb [ Time Frame: approximately 1-hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)
The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648920

Locations
United States, Pennsylvania
Allergy and Asthma Specialists, PC
Blue Bell, Pennsylvania, United States, 19422
Allergy and Asthma Specialists, PC
Collegeville, Pennsylvania, United States, 19426
Allergy and Asthma Specialists, PC
Doylestown, Pennsylvania, United States, 18901
Allergy and Asthma Specialists, PC
Jenkintown, Pennsylvania, United States, 19102
Allergy and Asthma Specialists, PC
King of Prussia, Pennsylvania, United States, 19406
Allergy and Asthma Specialists, PC
Lansdale, Pennsylvania, United States, 19446
Allergy and Asthma Specialists, PC
Philadelphia, Pennsylvania, United States, 19102
Allergy and Asthma Specialists, PC
Pottsville, Pennsylvania, United States, 19464
Sponsors and Collaborators
Aerocrine AB
Investigators
Principal Investigator: Robert Anolik, MD Allergy and Asthma Specialists, PC
  More Information

No publications provided

Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01648920     History of Changes
Other Study ID Numbers: AER-044
Study First Received: July 5, 2012
Results First Received: November 27, 2013
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Aerocrine AB:
Asthma
Suspected but undiagnosed asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Methacholine Chloride
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents
Miotics
Parasympathomimetics

ClinicalTrials.gov processed this record on August 26, 2014