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

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ClinicalTrials.gov Identifier: NCT00739531
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : August 21, 2008
Sponsor:
Information provided by:
Apieron

Brief Summary:
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 or disease Intervention/treatment
Asthma Device: Exhaled nitric oxide (eNO)

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.

Study Type : Observational
Estimated Enrollment : 150 participants
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
Study Start Date : October 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



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


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.
Criteria

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

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


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
Sponsors and Collaborators
Apieron

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

Keywords provided by Apieron:
Asthma
nitric oxide
eNO
FENO
Apieron INSIGHT
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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents