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NCT00739531 Clinical Trial

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

Asthma Clinical Trial

Official title:
Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00739531
Other study ID # CP00014
Secondary ID
Status Completed
Phase N/A
First received August 19, 2008
Last updated August 20, 2008
Start date October 2007
Est. completion date December 2007

Study information
Verified date August 2008
Source Apieron
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Allergy, Asthma & Dermatology Research Center, LLC Lake Oswego Oregon
United States The Asthma- Allergy Clinic& Research Center Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Apieron

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s Single point in time No
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