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

Apieron

Status: Completed

Conditions: Asthma

Treatments: Device: Exhaled nitric oxide (eNO)

Study type: Observational

Funder types: Industry

Identifiers

NCT00739531

CP00014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Asthmatics

Description:

Subjects with asthma

Treatment:

Device: Exhaled nitric oxide (eNO)