Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

This study has been completed.
Sponsor:
Information provided by:
Apieron
ClinicalTrials.gov Identifier:
NCT00739531
First received: August 19, 2008
Last updated: August 20, 2008
Last verified: August 2008

August 19, 2008
August 20, 2008
October 2007
December 2007   (final data collection date for primary outcome measure)
eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s [ Time Frame: Single point in time ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739531 on ClinicalTrials.gov Archive Site
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Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System
Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Up to 150 asthma patients recruited from the site center's population of patients.

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.
Asthmatics
Subjects with asthma
Intervention: Device: Exhaled nitric oxide (eNO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 5 or older
  • Pre-existing diagnosis of asthma
  • Non-smoker

Exclusion Criteria:

  • Chronic inflammatory lung disease other than asthma
  • Medical conditions that preclude hand-eye coordination
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739531
CP00014
No
Nina Peled, VP of Regulatory and Clinical Affairs, Apieron
Apieron
Not Provided
Not Provided
Apieron
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP