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

NCT01634620 | Completed Results

• 1 other identifier: AER-042
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease Number of participants: Approximately 200 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual Safety assessments: The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time that informed consent has been provided and during the study period Criteria for evaluations: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design subsequent studies in patients with chronic obstructive airways disease. Information collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Chronic Obstructive Airways Disease; Chronic Bronchitis; Chronic Emphysema; Asthma

Outcome Measures

Primary Outcomes (11)

• Spirometry Results: FEV1 (L)

  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.

  Single Visit

• Spirometry Results: FVC (L)

  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.

  Single Visit

• Spirometry Results: FEV1 (% Predicted)

  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.

  Single Visit

• Spirometry Results: FEF50% (L/Sec)

  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.

  Single Visit

• Spirometry Results: FEF25-75 (L/Sec)

  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.

  Single Visit

• Spirometry Results: PEF (L/Min)

  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.

  Single Visit

• FeNO Levels by GOLD Stage of Severity

  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.

  Single Visit

• FeNO Levels by Inhaled Corticosteroid Use

  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.

  Single Visit

• FeNO Levels by Smoking Status

  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.

  Single Visit

• FeNO Levels by ICD 9 Code Category

  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.

  Single Visit

• Mean FeNO Levels by ICD 9 Code Category

  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.

  Single Visit

Study Arms (1)

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)

Interventions

NIOX MINO® Instrument (09-1100) DEVICE

FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)

FeNO

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerocrine AB: lead

Study Sites (2)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

University of North Carolina Hospitals - Sanford Specialty Clinics

Sanford, North Carolina, 27330, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Nancy Herje, BSN, RN, MBA
• Organization: Aerocrine, Inc.

Nancy.Herje@aerocrine.com

919-449-8873

Study Officials

• James Donohue, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2014-01

Locations

US (2)