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| Sponsored by: |
Apieron |
| Information provided by: | Apieron |
| ClinicalTrials.gov Identifier: | NCT00739531 |
Purpose
Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath System when testing is performed by asthma patients.
| Condition | Intervention |
|
Asthma |
Device: Exhaled nitric oxide (eNO) |
| MedlinePlus related topics: | Asthma |
| ChemIDplus related topics: | Nitric oxide |
| Study Type: | Observational |
| Study Design: | Case-Only, Cross-Sectional |
| Official Title: | Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|
Asthmatics
Subjects with asthma
|
Device: Exhaled nitric oxide (eNO)
Subjects will perform a controlled breath maneuver using both the Apieron and NIOX devices. The devices will measure nitric oxide in the subjects' exhaled breath.
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A non-randomized, prospective study of up to 150 subjects with asthma. Patients will perform eNO testing with the Apieron INSIGHT(tm) eNO system and the NIOX eNO system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. Exhaled NO testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the Apieron INSIGHT(tm) and NIOX systems. Patients will perform an eNO measurement with the Apieron INSIGHT(tm) system and with the FDA cleared NIOX system for the accuracy portion of the study. Patients will perform 2 sequential eNO measurements on each system for the precision part of the study. Subjects that measure eNO values over 100 ppb will be asked to repeat 2 sequential eNO measurements on each system.
Eligibility
| Ages Eligible for Study: | 5 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Up to 150 asthma patients recruited from the site center's population of patients.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Louisiana | |||||
| The Asthma- Allergy Clinic& Research Center | |||||
| Shreveport, Louisiana, United States, 71105 | |||||
| United States, Oregon | |||||
| Allergy, Asthma & Dermatology Research Center, LLC | |||||
| Lake Oswego, Oregon, United States, 97035 | |||||
| Apieron |
More Information
| Responsible Party: | Apieron ( Nina Peled, VP of Regulatory and Clinical Affairs ) |
| Study ID Numbers: | CP00014 |
| First Received: | August 19, 2008 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00739531 |
| Health Authority: | United States: Institutional Review Board |
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