Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT01634620
Status:
COMPLETED
Last Update Posted:
2014-02-12
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nancy.Herje@aerocrine.com', 'phone': '919-449-8873', 'title': 'Nancy Herje, BSN, RN, MBA', 'organization': 'Aerocrine, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Single Visit', 'eventGroups': [{'id': 'EG000', 'title': 'FeNO', '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.\n\nNIOX 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)', 'otherNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Headache and Chest Discomfort', 'notes': 'adverse event that was considered serious, severe in severity, not related to performance of the FeNO maneuver, and required no action be taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retaining CO2, Jerky Movements', 'notes': 'adverse event that was considered serious, severe in severity, not related to performance of the FeNO maneuver, and required no action be taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Spirometry Results: FEV1 (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Spirometry Results: FVC (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.680', 'spread': '0.9326', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Spirometry Results: FEV1 (% Predicted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '22.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Percent Predicted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Spirometry Results: FEF50% (L/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '27.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Liters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Spirometry Results: FEF25-75 (L/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.759', 'spread': '0.6898', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Liters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Spirometry Results: PEF (L/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'categories': [{'measurements': [{'value': '244.6', 'spread': '107.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.", 'unitOfMeasure': 'Liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'FeNO Levels by GOLD Stage of Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'title': 'All Subjects (191 subjects)', 'categories': [{'measurements': [{'value': '15.3', 'spread': '17.18', 'groupId': 'OG000'}]}]}, {'title': 'Stage I (24 subjects)', 'categories': [{'measurements': [{'value': '13.7', 'spread': '6.88', 'groupId': 'OG000'}]}]}, {'title': 'Stage II (77 subjects)', 'categories': [{'measurements': [{'value': '18.5', 'spread': '24.43', 'groupId': 'OG000'}]}]}, {'title': 'Stage III (74 subjects)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '9.99', 'groupId': 'OG000'}]}]}, {'title': 'Stage IV (16 subjects)', 'categories': [{'measurements': [{'value': '13.0', 'spread': '8.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'FeNO Levels by Inhaled Corticosteroid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low FeNO', '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.\n\nNIOX 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).\n\nLow FeNo is defined as subjects with FeNo levels \\<25 parts per billion.'}, {'id': 'OG001', 'title': 'Moderate FeNO', '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.\n\nNIOX 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).\n\nModerate FeNO is defined as subjects with FeNO levels \\>=25 parts per billion (ppb) or \\<=50 ppb.'}, {'id': 'OG002', 'title': 'High FeNO', '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.\n\nNIOX 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).\n\nHigh FeNO subjects are defined as subjects with FeNO levels \\> 50 parts per billion.'}], 'classes': [{'title': 'Use Inhaled Corticosteroids', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Do Not Use Inhaled Corticosteroids', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Single Visit', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'FeNO Levels by Smoking Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low FeNO', '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.\n\nNIOX 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).\n\nLow FeNo is defined as subjects with FeNo levels \\<25 parts per billion.'}, {'id': 'OG001', 'title': 'Moderate FeNO', '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.\n\nNIOX 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).\n\nModerate FeNO is defined as subjects with FeNO levels \\>=25 parts per billion (ppb) or \\<=50 ppb.'}, {'id': 'OG002', 'title': 'High FeNO', '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.\n\nNIOX 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).\n\nHigh FeNO subjects are defined as subjects with FeNO levels \\> 50 parts per billion.'}], 'classes': [{'title': 'Previous or Current Smoker', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Single Visit', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'FeNO Levels by ICD 9 Code Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low FeNO', '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.\n\nNIOX 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).\n\nLow FeNo is defined as subjects with FeNo levels \\<25 parts per billion.'}, {'id': 'OG001', 'title': 'Moderate FeNO', '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.\n\nNIOX 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).\n\nModerate FeNO is defined as subjects with FeNO levels \\>=25 parts per billion (ppb) or \\<=50 ppb.'}, {'id': 'OG002', 'title': 'High FeNO', '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.\n\nNIOX 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).\n\nHigh FeNO subjects are defined as subjects with FeNO levels \\> 50 parts per billion.'}], 'classes': [{'title': 'COPD and Asthma', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'COPD and Emphysema', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'All other codes', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Single Visit', '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}, {'type': 'PRIMARY', 'title': 'Mean FeNO Levels by ICD 9 Code Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'classes': [{'title': 'COPD and Asthma', 'categories': [{'measurements': [{'value': '20.5', 'spread': '27.57', 'groupId': 'OG000'}]}]}, {'title': 'COPD and Emphysema', 'categories': [{'measurements': [{'value': '12.9', 'spread': '7.40', 'groupId': 'OG000'}]}]}, {'title': 'All other codes', 'categories': [{'measurements': [{'value': '12.9', 'spread': '8.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Single Visit', '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.', 'unitOfMeasure': 'parts per billion (ppb)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FeNO', '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.\n\nNIOX 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)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '11.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '191', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Past Smoker', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'At study visit, participants responded to a questionnaire regarding their smoking history. Participants were classified as having never smoked, current smoker, or past smoker.', 'unitOfMeasure': 'participants'}, {'title': 'Current Medications used for Pulmonary and/or Allergy Conditions', 'classes': [{'title': 'SABA', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}, {'title': 'ICS/LABA Combination', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}]}]}, {'title': 'LAMA', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}]}]}, {'title': 'Intranasal Corticosteroid', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'Leukotriene Receptor Antagonist', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'SABA/SAMA', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'ICS', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'H2-Receptor Antagonist', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Antihistamine', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Histamine H1-Receptor Antagonist', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'LABA', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'SAMA', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Corticosteroid', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Provided is a summary of medications taken by \\>= 5% of participants that are used for pulmonary and/or allergy conditions. The most common medications included short-acting bata-agonist bronchodilators (SABA), inhaled corticosteroid (ICS) and long-acting bata-agonist bronchodilators (LABA) combination products, long-acting antimuscarinic antagonists (LAMA), intranasal corticosteroids, leukotriene receptor antagonists, ICS, and combination SABA/SAMA (short-acting antimuscarinic antagonists)', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Per-protocol Population'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2012-07-03', 'resultsFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-15', 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometry Results: FEV1 (L)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'Spirometry Results: FVC (L)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'Spirometry Results: FEV1 (% Predicted)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'Spirometry Results: FEF50% (L/Sec)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'Spirometry Results: FEF25-75 (L/Sec)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'Spirometry Results: PEF (L/Min)', 'timeFrame': 'Single Visit', '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."}, {'measure': 'FeNO Levels by GOLD Stage of Severity', 'timeFrame': 'Single Visit', '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.'}, {'measure': 'FeNO Levels by Inhaled Corticosteroid Use', 'timeFrame': 'Single Visit', '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.'}, {'measure': 'FeNO Levels by Smoking Status', 'timeFrame': 'Single Visit', '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.'}, {'measure': 'FeNO Levels by ICD 9 Code Category', 'timeFrame': 'Single Visit', '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.'}, {'measure': 'Mean FeNO Levels by ICD 9 Code Category', 'timeFrame': 'Single Visit', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Chronic Obstructive Airways Disease', 'Chronic Bronchitis', 'Chronic Emphysema', 'Asthma'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease\n\nNumber of participants: Approximately 200 subjects will be enrolled\n\nReference product: NIOX MINO® Instrument (09-1100)\n\nPerformance 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\n\nSafety 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\n\nCriteria 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', 'detailedDescription': "INTRODUCTION\n\nOverview:\n\nThe 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.\n\nBurden of Disease:\n\nChronic 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.\n\nRole of Exhaled Nitric Oxide (FeNO):\n\nFeNO 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.\n\nCOPD 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.\n\nIntended Use:\n\nNIOX 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.\n\nRationale for Study:\n\nWhile 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\n\nCLINICAL INVESTIGATION OBJECTIVES To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease.\n\nCLINICAL INVESTIGATION PLAN\n\nThis 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:\n\n* Informed Consent\n* Demographics\n* Baseline Characteristics\n* FeNO:\n\n \\- Subjects will receive training by the study staff on use of the NIOX MINO® device to perform FeNO Measurements\n* Spirometry\n* Severity of COPD\n\nSubject discharge from the study:\n\nOnce 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\n\nSelection of investigation population:\n\nMale 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.\n\nMedical device:\n\nThe 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.\n\nThe 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.\n\nDefinitions:\n\nAdverse 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.\n\nSerious Injury means injury or illness that:\n\n* Is life-threatening\n* Results in permanent impairment of a body function or permanent damage to a body structure, or\n* Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.\n\nMalfunction: the failure of a device to meet its performance specifications or otherwise perform as intended.\n\nCaused 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:\n\n* Failure\n* Malfunction\n* Improper or inadequate design\n* Manufacture\n* Labeling\n* User error"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the UNC Hospital Outpatient Pulmonary Function Laboratory in Chapel Hill, NC and approximately 3 to 6 outpatient clinics associated with UNC who meet the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD.\n\nExclusion Criteria:\n\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01634620', 'briefTitle': 'Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aerocrine AB'}, 'officialTitle': 'Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease', 'orgStudyIdInfo': {'id': 'AER-042'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FeNO', '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.", 'interventionNames': ['Device: NIOX MINO® Instrument (09-1100)']}], 'interventions': [{'name': 'NIOX MINO® Instrument (09-1100)', 'type': 'DEVICE', 'description': 'FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)', 'armGroupLabels': ['FeNO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27330', 'city': 'Sanford', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals - Sanford Specialty Clinics', 'geoPoint': {'lat': 35.47988, 'lon': -79.1803}}], 'overallOfficials': [{'name': 'James Donohue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aerocrine AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}