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Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB
ClinicalTrials.gov Identifier:
NCT01634620
First received: July 3, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Device: NIOX MINO® Instrument (09-1100)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease

Resource links provided by NLM:


Further study details as provided by Aerocrine AB:

Primary Outcome Measures:
  • Spirometry Results: FEV1 (L) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 200
Study Start Date: June 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634620

Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
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
  More Information

Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01634620     History of Changes
Other Study ID Numbers: AER-042
Study First Received: July 3, 2012
Results First Received: August 30, 2013
Last Updated: January 15, 2014

Keywords provided by Aerocrine AB:
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Airways Disease
Chronic Bronchitis
Chronic Emphysema
Asthma

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 28, 2017