Trial Outcomes & Findings for Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease (NCT NCT01634620)
NCT ID: NCT01634620
Last Updated: 2014-02-12
Results Overview
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.
COMPLETED
200 participants
Single Visit
2014-02-12
Participant Flow
Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.
Participant milestones
| Measure |
FeNO
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)
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|---|---|
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Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
200
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|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Baseline characteristics by cohort
| Measure |
FeNO
n=191 Participants
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)
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|---|---|
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Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.34 • n=5 Participants
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Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
191 participants
n=5 Participants
|
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Smoking Status
Never Smoked
|
9 participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
58 participants
n=5 Participants
|
|
Smoking Status
Past Smoker
|
124 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
SABA
|
160 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
ICS/LABA Combination
|
144 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
LAMA
|
133 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
Intranasal Corticosteroid
|
40 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
Leukotriene Receptor Antagonist
|
28 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
SABA/SAMA
|
22 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
ICS
|
20 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
H2-Receptor Antagonist
|
18 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
Antihistamine
|
14 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
Histamine H1-Receptor Antagonist
|
12 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
LABA
|
12 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
SAMA
|
11 participants
n=5 Participants
|
|
Current Medications used for Pulmonary and/or Allergy Conditions
Corticosteroid
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
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|---|---|---|---|
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Spirometry Results: FEV1 (L)
|
1.4 Liters
Standard Deviation 0.67
|
—
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—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
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|---|---|---|---|
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Spirometry Results: FVC (L)
|
2.680 Liters
Standard Deviation 0.9326
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
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|---|---|---|---|
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Spirometry Results: FEV1 (% Predicted)
|
53.9 Percent Predicted
Standard Deviation 22.11
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
|
|---|---|---|---|
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Spirometry Results: FEF50% (L/Sec)
|
31.8 Liters per second
Standard Deviation 27.78
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
|
|---|---|---|---|
|
Spirometry Results: FEF25-75 (L/Sec)
|
0.759 Liters per second
Standard Deviation 0.6898
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
|
|---|---|---|---|
|
Spirometry Results: PEF (L/Min)
|
244.6 Liters per minute
Standard Deviation 107.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
|
|---|---|---|---|
|
FeNO Levels by GOLD Stage of Severity
Stage I (24 subjects)
|
13.7 parts per billion (ppb)
Standard Deviation 6.88
|
—
|
—
|
|
FeNO Levels by GOLD Stage of Severity
Stage II (77 subjects)
|
18.5 parts per billion (ppb)
Standard Deviation 24.43
|
—
|
—
|
|
FeNO Levels by GOLD Stage of Severity
Stage III (74 subjects)
|
13.0 parts per billion (ppb)
Standard Deviation 9.99
|
—
|
—
|
|
FeNO Levels by GOLD Stage of Severity
All Subjects (191 subjects)
|
15.3 parts per billion (ppb)
Standard Deviation 17.18
|
—
|
—
|
|
FeNO Levels by GOLD Stage of Severity
Stage IV (16 subjects)
|
13.0 parts per billion (ppb)
Standard Deviation 8.01
|
—
|
—
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=170 Participants
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)
|
Moderate FeNO
n=16 Participants
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.
|
High FeNO
n=5 Participants
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.
|
|---|---|---|---|
|
FeNO Levels by Inhaled Corticosteroid Use
Use Inhaled Corticosteroids
|
143 participants
|
14 participants
|
4 participants
|
|
FeNO Levels by Inhaled Corticosteroid Use
Do Not Use Inhaled Corticosteroids
|
27 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Single VisitForced 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.
Outcome measures
| Measure |
FeNO
n=170 Participants
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)
|
Moderate FeNO
n=16 Participants
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.
|
High FeNO
n=5 Participants
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.
|
|---|---|---|---|
|
FeNO Levels by Smoking Status
Never Smoked
|
8 participants
|
1 participants
|
0 participants
|
|
FeNO Levels by Smoking Status
Previous or Current Smoker
|
162 participants
|
15 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=170 Participants
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)
|
Moderate FeNO
n=16 Participants
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.
|
High FeNO
n=5 Participants
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.
|
|---|---|---|---|
|
FeNO Levels by ICD 9 Code Category
COPD and Asthma
|
50 participants
|
7 participants
|
4 participants
|
|
FeNO Levels by ICD 9 Code Category
COPD and Emphysema
|
46 participants
|
4 participants
|
0 participants
|
|
FeNO Levels by ICD 9 Code Category
All other codes
|
74 participants
|
5 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Single VisitPopulation: Per-protocol Population
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.
Outcome measures
| Measure |
FeNO
n=191 Participants
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)
|
Moderate FeNO
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.
|
High FeNO
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.
|
|---|---|---|---|
|
Mean FeNO Levels by ICD 9 Code Category
COPD and Asthma
|
20.5 parts per billion (ppb)
Standard Deviation 27.57
|
—
|
—
|
|
Mean FeNO Levels by ICD 9 Code Category
COPD and Emphysema
|
12.9 parts per billion (ppb)
Standard Deviation 7.40
|
—
|
—
|
|
Mean FeNO Levels by ICD 9 Code Category
All other codes
|
12.9 parts per billion (ppb)
Standard Deviation 8.21
|
—
|
—
|
Adverse Events
FeNO
Serious adverse events
| Measure |
FeNO
n=200 participants at risk
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)
|
|---|---|
|
Cardiac disorders
Headache and Chest Discomfort
|
0.50%
1/200 • Number of events 1 • Single Visit
|
|
Investigations
Retaining CO2, Jerky Movements
|
0.50%
1/200 • Number of events 1 • Single Visit
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place