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

NCT ID: NCT00739531

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Keywords

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Asthma nitric oxide eNO FENO Apieron INSIGHT Aerocrine NIOX

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Asthmatics

Subjects with asthma

Exhaled nitric oxide (eNO)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apieron

INDUSTRY

Sponsor Role lead

Responsible Party

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Apieron

Locations

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The Asthma- Allergy Clinic& Research Center

Shreveport, Louisiana, United States

Site Status

Allergy, Asthma & Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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CP00014

Identifier Type: -

Identifier Source: org_study_id