NCT00739531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
Last Updated

August 21, 2008

Status Verified

August 1, 2008

Enrollment Period

2 months

First QC Date

August 19, 2008

Last Update Submit

August 20, 2008

Conditions

Asthma

Keywords

Asthmanitric oxideeNOFENOApieron INSIGHTAerocrine NIOX

Outcome Measures

Primary Outcomes (1)

  • eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s

    Single point in time

Study Arms (1)

Asthmatics

Subjects with asthma

Device: Exhaled nitric oxide (eNO)

Interventions

Exhaled nitric oxide (eNO)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.

Asthmatics

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 150 asthma patients recruited from the site center's population of patients.

You may qualify if:

  • Age 5 or older
  • Pre-existing diagnosis of asthma
  • Non-smoker

You may not qualify if:

  • Chronic inflammatory lung disease other than asthma
  • Medical conditions that preclude hand-eye coordination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Asthma- Allergy Clinic& Research Center

Shreveport, Louisiana, 71105, United States

Location

Allergy, Asthma & Dermatology Research Center, LLC

Lake Oswego, Oregon, 97035, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fractional Exhaled Nitric Oxide Testing

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Breath TestsDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 21, 2008

Record last verified: 2008-08

Locations

US(2)