N/A
Completed N=50
Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age
Source: ClinicalTrials.gov NCT01729247 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: FeNO Values by ACT Score — 40.3; 26.3 parts per billion (ppb)
Summary
Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions.
Secondary objectives: Evaluate the ability of physicians to correctly assess airway inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement). Estimate the cost consequences of changes in asthma management following FeNO determinations
Number of participants: Approximately 40 to 50 subjects will participate in the study during an (approximately) 8-12 week study enrollment period.
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 (February, 2011).
Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4) FeNO has been measured and seen by the Physician/Health Care Practitioner.
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 (CIP) from the time that informed consent has been provided and during the study period
Criteria for evaluation: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may be used to design subsequent studies in subjects with asthma. Data 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 FeNO Values by ACT Score |
40.3; 26.3 | — |
| PRIMARY FeNO Categorical Levels by ICS Use |
18; 11; 6; 4; 5; 6 | — |
| SECONDARY Physician Assessment of Airway Inflammation |
31.4; 40.6; 42.0 | — |
| SECONDARY Number of Participants Correctly Categorized by True Level of Airway Inflammation |
21; 3; 1 | — |
| SECONDARY Asthma Management Changes After FeNO Results Were Considered |
32; 9; 8; 6; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age: 7 to 60 years of age, inclusive
- Sex: Males and Females
- Diagnosis: Asthma
Exclusion Criteria
- Concurrent Conditions or Disease: Subjects with an established diagnosis of chronic, obstructive pulmonary disease (COPD) cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, or vocal cord dysfunction are excluded from participation
- Cigarette Smoking: Subjects with greater than a 10 pack-year history of cigarette smoking are excluded from participation
- 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 from participation
Data sourced from ClinicalTrials.gov (NCT01729247). 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.