Ignite Creation Date:
2024-05-06 @ 12:44 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01648920
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2012-07-05
Brief 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
Sponsor:
Aerocrine AB
Organization:
Aerocrine AB
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 US 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 mlsecond 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 clinicians 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
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 US 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 mlsecond 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 clinicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None