N/A
Completed N=200
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
Source: ClinicalTrials.gov NCT01634620 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Feb 2014
Primary outcomePrimary: Spirometry Results: FEV1 (L) — 1.4 Liters
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spirometry Results: FEV1 (L) |
1.4 | — |
| PRIMARY Spirometry Results: FVC (L) |
2.680 | — |
| PRIMARY Spirometry Results: FEV1 (% Predicted) |
53.9 | — |
| PRIMARY Spirometry Results: FEF50% (L/Sec) |
31.8 | — |
| PRIMARY Spirometry Results: FEF25-75 (L/Sec) |
0.759 | — |
| PRIMARY Spirometry Results: PEF (L/Min) |
244.6 | — |
| PRIMARY FeNO Levels by GOLD Stage of Severity |
15.3; 13.7; 18.5; 13.0; 13.0 | — |
| PRIMARY FeNO Levels by Inhaled Corticosteroid Use |
143; 14; 4; 27; 2; 1 | — |
| PRIMARY FeNO Levels by Smoking Status |
162; 15; 5; 8; 1; 0 | — |
| PRIMARY FeNO Levels by ICD 9 Code Category |
50; 7; 4; 46; 4; 0 | — |
| PRIMARY Mean FeNO Levels by ICD 9 Code Category |
20.5; 12.9; 12.9 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01634620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.