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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 21, 2008
Last Update Posted: August 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Resource links provided by NLM:

Further study details as provided by Apieron:

Primary Outcome Measures:
  • eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s [ Time Frame: Single point in time ]

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
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.

Detailed Description:
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 150 asthma patients recruited from the site center's population of patients.

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739531

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
Sponsors and Collaborators
  More Information

Responsible Party: Nina Peled, VP of Regulatory and Clinical Affairs, Apieron
ClinicalTrials.gov Identifier: NCT00739531     History of Changes
Other Study ID Numbers: CP00014
First Submitted: August 19, 2008
First Posted: August 21, 2008
Last Update Posted: August 21, 2008
Last Verified: August 2008

Keywords provided by Apieron:
nitric oxide
Aerocrine NIOX

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents