Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Objective: To characterize FeNO levels that may be indicative of eosinophilic airway
inflammation in patients with chronic obstructive airways disease
Number of participants: Approximately 200 subjects will be enrolled
Reference product: NIOX MINO® Instrument (09-1100)
Performance assessments: 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
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 observational, pilot study and there are currently no
plans for a formal statistical analysis. Information gained from this study may used to
design subsequent studies in patients with chronic obstructive airways disease. Information
collected will be summarized in a clinical study report but will not be subject to formal
hypothesis testing
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 and its symptoms. 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.
Burden of Disease:
Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of diseases
characterized by chronic airflow obstruction that interferes with normal breathing . The
Centers for Disease Control and Prevention (CDC) reported that in the year 2005,
approximately one in 20 deaths in the United States had COPD as the underlying cause.
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.
COPD can coexist with asthma. However, the exact role of FeNO in patients with established
COPD remains to be the defined. While COPD airway inflammation is usually associated with
increased neutrophils, some patients with COPD may have features of asthma such as a mixed
inflammatory pattern with increased eosinophils. However, many patients have difficulty
expectorating sputum and/or can only produce poor quality sputum samples which are not
adequate to accurately quantify eosinophilic cells. Since FeNO can be measured easily and
reliably, it may be useful in evaluating airway inflammation in COPD and thus predicting
steroid responsiveness in COPD.
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:
While there have been a number of preliminary studies on FeNO in COPD, literature defining
the role of FeNO in patients with established COPD is minimal. The purpose of the current
study, therefore is to characterize FeNO levels that may be indicative of eosinophilic
airway inflammation in patients with chronic obstructive airways disease. This data may be
useful in determining whether or not FeNO can predict improvement in FEV1 following ICS
treatment
CLINICAL INVESTIGATION OBJECTIVES To characterize FeNO levels that may be indicative of
eosinophilic airway inflammation in patients with chronic obstructive airways disease.
CLINICAL INVESTIGATION PLAN
This is a pilot, observational, multi-center, single-visit, outpatient study. Subjects
meeting all of the Inclusion Criteria and none of the Exclusion Criteria, and who express
interest in study participation, will be asked to provide the following documentation and
information:
- Informed Consent
- Demographics
- Baseline Characteristics
- FeNO:
- Subjects will receive training by the study staff on use of the NIOX MINO® device to
perform FeNO Measurements
- Spirometry
- Severity of COPD
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
Selection of investigation population:
Male and female subjects, age 40 years and above, inclusive, with chronic obstructive
pulmonary disease (COPD) including chronic bronchitis and emphysema and/or a mixed diagnosis
of asthma/COPD will be recruited. A subject should be withdrawn from the clinical
investigation if, in the opinion of the Investigator, it is medically necessary, or if it is
the expressed wish of the subject.
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
;
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