Status:

COMPLETED

Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms

Lead Sponsor:

Aerocrine AB

Conditions:

Asthma

Eligibility:

All Genders

7-65 years

Brief Summary

Overall Aim: To better understand the diagnostic process for prolonged respiratory events and determine the potential role of FeNO in assessing the possibility of asthma as the symptoms etiology. St...

Detailed Description

INTRODUCTION: Overview: The measurement of exhaled nitric oxide (FeNO) is the only clinical test for measuring airway inflammation that can be performed consistently and accurately in clinical pract...

Eligibility Criteria

Inclusion

  • Symptoms: Must have non-specific lower respiratory symptoms, such as cough, wheeze, and/or shortness of breath
  • Age: Seven (7) to 65 years, inclusive
  • Sex: Males and Females
  • Ability to successfully perform assessment of FeNO: Investigators should use their judgment to determine if study candidates will be able to successfully perform assessment of FeNO using the NIOX MINO®.

Exclusion

  • Diagnosis: No previous or current diagnosis of asthma or chronic obstructive pulmonary disease (COPD).
  • Medications: No use of inhaled or oral corticosteroids within 7 days prior to the visit.
  • Study Participation Outside of This Protocol: Patients currently enrolled in studies of Investigational or non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded.

Key Trial Info

Start Date :

November 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2012

Estimated Enrollment :

235 Patients enrolled

Trial Details

Trial ID

NCT01518322

Start Date

November 1 2011

End Date

February 1 2012

Last Update

August 30 2013

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Olmstead Medical Center Byron

Byron, Minnesota, United States, 55920

2

Olmstead Medical Center Chatfield

Chatfield, Minnesota, United States, 55923

3

Olmstead Medical Center Pine Island

Pine Island, Minnesota, United States, 55963

4

Olmstead Medical Center Plainview

Plainview, Minnesota, United States, 55964