Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Completed
Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)
In brief
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
Key facts
- Study ID
- NCT01634620
- Run by
- Aerocrine AB
- People needed
- 200
- Starts
- 2012-06-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2014-02-12
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
- University of North Carolina Hospitals - Sanford Specialty Clinics — Sanford, North Carolina, United States
Full record on ClinicalTrials.gov
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