Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| FeNO Participants with chronic obstructive pulmonary disease (COPD) 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. |
Device: NIOX MINO® Instrument (09-1100)
FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)
|
Outcome Measures
Primary Outcome Measures
- Spirometry Results: FEV1 (L) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- Spirometry Results: FVC (L) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- Spirometry Results: FEV1 (% Predicted) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- Spirometry Results: FEF50% (L/Sec) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- Spirometry Results: FEF25-75 (L/Sec) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- Spirometry Results: PEF (L/Min) [Single Visit]
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.
- FeNO Levels by GOLD Stage of Severity [Single Visit]
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.
- FeNO Levels by Inhaled Corticosteroid Use [Single Visit]
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.
- FeNO Levels by Smoking Status [Single Visit]
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.
- FeNO Levels by ICD 9 Code Category [Single Visit]
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
- Mean FeNO Levels by ICD 9 Code Category [Single Visit]
Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD.
Exclusion Criteria:
-
Concurrent Conditions or Disease: Subjects with other chronic obstructive lung diseases including but not limited to cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, vocal cord dysfunction, rhinosinusitis, non-eosinophilic asthma, and reactive airways dysfunction syndrome are excluded. In addition, subjects with pneumothorax, fractured rib(s), or signs of cardiac instability including but not limited to a recent myocardial infarction, unstable angina, unstable vital signs, or acute shortness of breath, chest tightness or chest pain are excluded.
-
Study Participation Outside of This 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of North Carolina Hospitals | Chapel Hill | North Carolina | United States | 27599 |
| 2 | University of North Carolina Hospitals - Sanford Specialty Clinics | Sanford | North Carolina | United States | 27330 |
Sponsors and Collaborators
- Aerocrine AB
Investigators
- Principal Investigator: James Donohue, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AER-042
Study Results
Participant Flow
| Recruitment Details | Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Period Title: Overall Study | |
| STARTED | 200 |
| COMPLETED | 200 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Overall Participants | 191 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
63.9
(11.34)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
111
58.1%
|
| Male |
80
41.9%
|
| Region of Enrollment (participants) [Number] | |
| United States |
191
100%
|
| Smoking Status (participants) [Number] | |
| Never Smoked |
9
4.7%
|
| Current Smoker |
58
30.4%
|
| Past Smoker |
124
64.9%
|
| Current Medications used for Pulmonary and/or Allergy Conditions (participants) [Number] | |
| SABA |
160
83.8%
|
| ICS/LABA Combination |
144
75.4%
|
| LAMA |
133
69.6%
|
| Intranasal Corticosteroid |
40
20.9%
|
| Leukotriene Receptor Antagonist |
28
14.7%
|
| SABA/SAMA |
22
11.5%
|
| ICS |
20
10.5%
|
| H2-Receptor Antagonist |
18
9.4%
|
| Antihistamine |
14
7.3%
|
| Histamine H1-Receptor Antagonist |
12
6.3%
|
| LABA |
12
6.3%
|
| SAMA |
11
5.8%
|
| Corticosteroid |
10
5.2%
|
Outcome Measures
| Title | Spirometry Results: FEV1 (L) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Liters] |
1.4
(0.67)
|
| Title | Spirometry Results: FVC (L) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Liters] |
2.680
(0.9326)
|
| Title | Spirometry Results: FEV1 (% Predicted) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Percent Predicted] |
53.9
(22.11)
|
| Title | Spirometry Results: FEF50% (L/Sec) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Liters per second] |
31.8
(27.78)
|
| Title | Spirometry Results: FEF25-75 (L/Sec) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Liters per second] |
0.759
(0.6898)
|
| Title | Spirometry Results: PEF (L/Min) |
|---|---|
| Description | Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| Mean (Standard Deviation) [Liters per minute] |
244.6
(107.27)
|
| Title | FeNO Levels by GOLD Stage of Severity |
|---|---|
| Description | Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| All Subjects (191 subjects) |
15.3
(17.18)
|
| Stage I (24 subjects) |
13.7
(6.88)
|
| Stage II (77 subjects) |
18.5
(24.43)
|
| Stage III (74 subjects) |
13.0
(9.99)
|
| Stage IV (16 subjects) |
13.0
(8.01)
|
| Title | FeNO Levels by Inhaled Corticosteroid Use |
|---|---|
| Description | Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | Low FeNO | Moderate FeNO | High FeNO |
|---|---|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Low FeNo is defined as subjects with FeNo levels <25 parts per billion. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion. |
| Measure Participants | 170 | 16 | 5 |
| Use Inhaled Corticosteroids |
143
74.9%
|
14
NaN
|
4
NaN
|
| Do Not Use Inhaled Corticosteroids |
27
14.1%
|
2
NaN
|
1
NaN
|
| Title | FeNO Levels by Smoking Status |
|---|---|
| Description | Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Low FeNO | Moderate FeNO | High FeNO |
|---|---|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Low FeNo is defined as subjects with FeNo levels <25 parts per billion. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion. |
| Measure Participants | 170 | 16 | 5 |
| Previous or Current Smoker |
162
84.8%
|
15
NaN
|
5
NaN
|
| Never Smoked |
8
4.2%
|
1
NaN
|
0
NaN
|
| Title | FeNO Levels by ICD 9 Code Category |
|---|---|
| Description | Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | Low FeNO | Moderate FeNO | High FeNO |
|---|---|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Low FeNo is defined as subjects with FeNo levels <25 parts per billion. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb. | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion. |
| Measure Participants | 170 | 16 | 5 |
| COPD and Asthma |
50
26.2%
|
7
NaN
|
4
NaN
|
| COPD and Emphysema |
46
24.1%
|
4
NaN
|
0
NaN
|
| All other codes |
74
38.7%
|
5
NaN
|
1
NaN
|
| Title | Mean FeNO Levels by ICD 9 Code Category |
|---|---|
| Description | Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases. |
| Time Frame | Single Visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-protocol Population |
| Arm/Group Title | FeNO |
|---|---|
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) had 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. NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) |
| Measure Participants | 191 |
| COPD and Asthma |
20.5
(27.57)
|
| COPD and Emphysema |
12.9
(7.40)
|
| All other codes |
12.9
(8.21)
|
Adverse Events
| Time Frame | Single Visit | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | FeNO | |
| Arm/Group Description | Participants with chronic obstructive pulmonary disease (COPD) 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. NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011) | |
All Cause Mortality |
||
| FeNO | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| FeNO | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/200 (1%) | |
| Cardiac disorders | ||
| Headache and Chest Discomfort | 1/200 (0.5%) | 1 |
| Investigations | ||
| Retaining CO2, Jerky Movements | 1/200 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| FeNO | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/200 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nancy Herje, BSN, RN, MBA |
|---|---|
| Organization | Aerocrine, Inc. |
| Phone | 919-449-8873 |
| Nancy.Herje@aerocrine.com |
- AER-042