Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age
Completed
Conditions studied: Asthma
In brief
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
Key facts
- Study ID
- NCT01729247
- Run by
- Aerocrine AB
- People needed
- 50
- Starts
- 2012-10-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2014-03-03
Who can join
Age: 7 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 7 to 60 years of age, inclusive
- Sex: Males and Females
- Diagnosis: Asthma
You may not qualify if…
- 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
Where it is running
- North Carolina Clinical Research — Raleigh, North Carolina, United States
Full record on ClinicalTrials.gov
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