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
  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)

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 ] [ Designated as safety issue: No ]

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.

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nina Peled, VP of Regulatory and Clinical Affairs, Apieron
ClinicalTrials.gov Identifier: NCT00739531     History of Changes
Other Study ID Numbers: CP00014
Study First Received: August 19, 2008
Last Updated: August 20, 2008
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014