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

NCT01518322 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 235

Last updated 2013-08-30

Study results available
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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.

Study Objectives:

The specific objectives of this study are to:

* Determine the frequency of ICS prescription for the treatment of non-specific lower respiratory symptoms.
* Determine the frequency of asthma diagnosis as an etiology for the non-specific lower respiratory symptoms.
* Explore the value of FeNO in identifying asthma as the etiology of the non-specific lower respiratory symptoms.

Number of Subjects:

It is anticipated that up to approximately 3,000 patients will be asked to complete the brief screening questionnaire that will be used to identify up to approximately 280 eligible patients who meet the study inclusion/exclusion criteria during a (approximately) 4 to 6 week study enrollment period.

Reference Product: NIOX MINO®

Duration of the participants involvement in the investigation: Single Visit

Performance assessments:

Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed using the NIOX MINO® device according to "Instructions for NO measurements" which will be provided to each Investigative site prior to patient enrollment.

Safety Assessments:

The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time of informed consent/assent and during the study period.

Criteria for Evaluation:

The relationship(s) between FeNO and both the diagnosis of asthma and prescription of ICS will be explored by correlation, measures of concordance and logistic modeling.

Conditions

Interventions

DEVICE

NIOX MINO®

Fractional Exhaled Nitric Oxide (FeNO) will be measured with the NIOX MINO®

Sponsors & Collaborators

  • Aerocrine AB

    lead INDUSTRY

Principal Investigators

  • Nancy Herje, BSN, RN, MBA · Aerocrine, Inc.

  • Barbara Yawn, MD, MSc · Olmsted Medical Center

Eligibility

Min Age
7 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518322 on ClinicalTrials.gov