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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB
ClinicalTrials.gov Identifier:
NCT01518322
First received: November 11, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Asthma
Device: NIOX MINO®

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational, Multi-Center, Single-Visit Study to Assess the Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms

Resource links provided by NLM:


Further study details as provided by Aerocrine AB:

Primary Outcome Measures:
  • Relationship Between FeNO and the Diagnosis of Asthma [ Time Frame: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1) ] [ Designated as safety issue: No ]
    For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.

  • Relationship Between FeNO and the Prescription of ICS in Primary Care Practices [ Time Frame: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1) ] [ Designated as safety issue: No ]
    The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.


Secondary Outcome Measures:
  • Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study [ Time Frame: anytime prior to the single study visit ] [ Designated as safety issue: No ]
    The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.


Enrollment: 235
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
FeNO
All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Device: NIOX MINO®
Fractional Exhaled Nitric Oxide (FeNO) will be measured with the NIOX MINO®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Any person visiting a primary care clinic.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518322

Locations
United States, Minnesota
Olmstead Medical Center Byron
Byron, Minnesota, United States, 55920
Olmstead Medical Center Chatfield
Chatfield, Minnesota, United States, 55923
Olmstead Medical Center Pine Island
Pine Island, Minnesota, United States, 55963
Olmstead Medical Center Plainview
Plainview, Minnesota, United States, 55964
Olmstead Medical Center Preston
Preston, Minnesota, United States, 55965
Olmstead Medical Center - Allergy Department
Rochester, Minnesota, United States, 55904
Olmstead Medical Center - Family Medicine Department
Rochester, Minnesota, United States, 55904
Olmsted Medical Center - Internal Medicine Department
Rochester, Minnesota, United States, 55904
Olmstead Medical Center Northwest
Rochester, Minnesota, United States, 55901
Olmstead Medical Center Spring Valley
Spring Valley, Minnesota, United States, 55975
Olmstead Medical Center St. Charles
St. Charles, Minnesota, United States, 55972
Olmstead Medical Center Stewartville
Stewartville, Minnesota, United States, 55976
Olmstead Medical Center Wanamingo
Wanamingo, Minnesota, United States, 55983
Sponsors and Collaborators
Aerocrine AB
Investigators
Study Director: Nancy Herje, BSN, RN, MBA Aerocrine, Inc.
Principal Investigator: Barbara Yawn, MD, MSc Olmsted Medical Center
  More Information

No publications provided

Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01518322     History of Changes
Other Study ID Numbers: AER-040
Study First Received: November 11, 2011
Results First Received: March 16, 2013
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Aerocrine AB:
Asthma
Fractional Exhaled Nitric Oxide
Respiratory Symptoms
NIOX MINO
Inhaled corticosteroids
Nitric Oxide

Additional relevant MeSH terms:
Asthma
Signs and Symptoms, Respiratory
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 27, 2014