AsthmaNCT01648920
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
An observational study of Asthma, run by Aerocrine AB at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- NIOX MINO® Instrument (09-1100)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to Nov 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Subjects with suspected but undiagnosed asthma that are scheduled to undergo MCC testing as part of the routine evaluation of suspected asthma.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Allergy and Asthma Specialists, PC
Blue Bell, Pennsylvania, 19422
Allergy and Asthma Specialists, PC
Collegeville, Pennsylvania, 19426
Allergy and Asthma Specialists, PC
Doylestown, Pennsylvania, 18901
Allergy and Asthma Specialists, PC
Jenkintown, Pennsylvania, 19102
Allergy and Asthma Specialists, PC
King of Prussia, Pennsylvania, 19406
Allergy and Asthma Specialists, PC
Lansdale, Pennsylvania, 19446
Allergy and Asthma Specialists, PC
Philadelphia, Pennsylvania, 19102
Allergy and Asthma Specialists, PC
Pottsville, Pennsylvania, 19464
About this study
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
Read more
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
Read the detailed description
INTRODUCTION
Overview:
The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical practice at the point-of-care. Airway inflammation is now recognized as the central mechanism in the pathogenesis of asthma. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway diseases such as asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Role of Exhaled Nitric Oxide (FeNO):
FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part of the inflammatory process.
Measuring the amount of FeNO is useful in the initial assessment of patients with chronic cough or non-specific respiratory symptoms suggestive of asthma, and for the management of patients with established asthma who are receiving corticosteroid treatment.
Intended Use:
NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and according to guidelines for NO measurement established by the American Thoracic Society.
Rationale for Study:
The burden of asthma in the U.S. is significant and growing. In addition, it has been established that asthma is both over- and under- diagnosed. Equally concerning is the fact that nearly 75% of these misdiagnosed patients are receiving anti-asthma treatments. Data such as these point out the need for a simple, inexpensive and reliable way to establish the diagnosis of asthma.
Presently, the assessment of patients with suspected but undiagnosed asthma is to perform Methacholine Challenge (MCC) testing to evaluate airway hyperresponsiveness. However, MCC, testing is difficult, time-consuming, and costly and also involves some level of risk to the patient. Nonetheless, there is some evidence that FeNO testing may be able to identify the patients who actually have asthma among those with suspected but undiagnosed asthma who have normal pulmonary function tests, thus potentially eliminating the need for MCC testing in many patients.
CLINICAL INVESTIGATION OBJECTIVES To explore the utility of FeNO compared with MCC in assessing patients with suspected but undiagnosed asthma.
CLINICAL INVESTIGATION PLAN
This is an exploratory, multi-center, single-visit, outpatient study. Approximately 50 subjects will participate in the study during an (approximately 8-16 week study enrollment period:
- Demographics
- Physical Characteristics
- Smoking history (cigarettes only)
- FeNO
- Spirometry
- Asthma and Allergy Specialists MCC Test Procedure
Subject discharge from the study:
Once all information has been collected and all procedures have been performed, the subject will be discharged from the clinic and their study participation will be complete
Medical device:
The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation. The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in adults 18 years of age or older in the initial assessment and management of asthma.
The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate. Results are provided at the point of care within 2 minutes after the successful completion of the breath test. The test cannot be influenced by patient effort or variations in the clinician's test technique.
Definitions:
Adverse event: Any incident where the use of a medical device (including in vitro diagnostics) is suspected to have resulted in an adverse outcome in a patient.
Serious Injury means injury or illness that:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure, or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Malfunction: the failure of a device to meet its performance specifications or otherwise perform as intended.
Caused or contributed: the death or serous injury was or may have been attributed to a medical device, or that the medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
- Failure
- Malfunction
- Improper or inadequate design
- Manufacture
- Labeling
- User error
- Conditions
- Asthma
- Being tested
- NIOX MINO® Instrument (09-1100)
- Keywords
- Asthma, Suspected but undiagnosed asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NIOX MINO® Instrument (09-1100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: approximately 1-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerocrine AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Anolik, MD, Principal investigator, Allergy and Asthma Specialists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648920
- Sponsor's protocol ID
- AER-044
- Status last verified
- Apr 2014
- First submitted
- 5 Jul 2012
- Last updated
- 9 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01648920
- Acronym / sponsor ID
- AER-044
- Conditions
- Asthma
- Keywords
- Asthma, Suspected but undiagnosed asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aerocrine ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Posted 9 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
INTRODUCTION
Overview:
The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical practice at the point-of-care. Airway inflammation is now recognized as the central mechanism in the pathogenesis of asthma. The measurement of FeNO with the NIOX MINO® device provides a rapid, noninvasive, and inexpensive tool to assess airway inflammation in inflammatory airway diseases such as asthma. The test is easy to perform and requires minimal training for the operator to conduct the test.
Role of Exhaled Nitric Oxide (FeNO):
FeNO has evolved as a predictive and prognostic biomarker for airway inflammation. Nitric oxide (NO) gas is produced in the epithelial cells of the bronchial wall as an intrinsic part of the inflammatory process.
Measuring the amount of FeNO is useful in the initial assessment of patients with chronic cough or non-specific respiratory symptoms suggestive of asthma, and for the management of patients with established asthma who are receiving corticosteroid treatment.
Intended Use:
NIOX MINO® measures Nitric Oxide (NO) in human breath. Nitric Oxide is frequently increased in inflammatory processes such as asthma. The fractional NO concentration in expired breath (FeNO) can be measured by NIOX MINO® with assurance that such measurements are repeatable and according to guidelines for NO measurement established by the American Thoracic Society.
Rationale for Study:
The burden of asthma in the U.S. is significant and growing. In addition, it has been established that asthma is both over- and under- diagnosed. Equally concerning is the fact that nearly 75% of these misdiagnosed patients are receiving anti-asthma treatments. Data such as these point out the need for a simple, inexpensive and reliable way to establish the diagnosis of asthma.
Presently, the assessment of patients with suspected but undiagnosed asthma is to perform Methacholine Challenge (MCC) testing to evaluate airway hyperresponsiveness. However, MCC, testing is difficult, time-consuming, and costly and also involves some level of risk to the patient. Nonetheless, there is some evidence that FeNO testing may be able to identify the patients who actually have asthma among those with suspected but undiagnosed asthma who have normal pulmonary function tests, thus potentially eliminating the need for MCC testing in many patients.
CLINICAL INVESTIGATION OBJECTIVES To explore the utility of FeNO compared with MCC in assessing patients with suspected but undiagnosed asthma.
CLINICAL INVESTIGATION PLAN
This is an exploratory, multi-center, single-visit, outpatient study. Approximately 50 subjects will participate in the study during an (approximately 8-16 week study enrollment period:
- Demographics
- Physical Characteristics
- Smoking history (cigarettes only)
- FeNO
- Spirometry
- Asthma and Allergy Specialists MCC Test Procedure
Subject discharge from the study:
Once all information has been collected and all procedures have been performed, the subject will be discharged from the clinic and their study participation will be complete
Medical device:
The NIOX MINO® was initially cleared by the FDA on March 4, 2008 as a new hand-held device for the measurement of exhaled Nitric Oxide, a marker of eosinophilic airway inflammation. The most recent clearance by the FDA was on September 2, 2010 for Instrument (09-1100), which will be used in this study. NIOX MINO® can be used in children 7-17 years of age and in adults 18 years of age or older in the initial assessment and management of asthma.
The NIOX MINO® is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate. Results are provided at the point of care within 2 minutes after the successful completion of the breath test. The test cannot be influenced by patient effort or variations in the clinician's test technique.
Definitions:
Adverse event: Any incident where the use of a medical device (including in vitro diagnostics) is suspected to have resulted in an adverse outcome in a patient.
Serious Injury means injury or illness that:
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to a body structure, or
- Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Malfunction: the failure of a device to meet its performance specifications or otherwise perform as intended.
Caused or contributed: the death or serous injury was or may have been attributed to a medical device, or that the medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
- Failure
- Malfunction
- Improper or inadequate design
- Manufacture
- Labeling
- User error
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FeNO | – | Device: NIOX MINO® Instrument (09-1100)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 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subjects with suspected but undiagnosed asthma that are scheduled to undergo MCC testing as part of the routine evaluation of suspected asthma.
Key exclusion criteria (14 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | FeNO |
Primary outcome
Methacholine Challenge (MCC) Results
Time frame: approximately 1-hour
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Anolik, MD principal investigator
Allergy and Asthma Specialists, PC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Aerocrine AB at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methacholine Challenge (MCC) Results (time frame: approximately 1-hour). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.