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

NCT01518322 | Completed Results

• 1 other identifier: AER-040
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 13

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. 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

Asthma

Keywords

Asthma; Fractional Exhaled Nitric Oxide; Respiratory Symptoms; NIOX MINO; Inhaled corticosteroids; Nitric Oxide

Outcome Measures

Primary Outcomes (2)

• Relationship Between FeNO and the Diagnosis of Asthma

  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.

  Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)

• Relationship Between FeNO and the Prescription of ICS in Primary Care Practices

  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.

  Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)

Secondary Outcomes (1)

• Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study

  anytime prior to the single study visit

Study Arms (1)

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®

Interventions

NIOX MINO® DEVICE

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

FeNO

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person visiting a primary care clinic.

You may qualify if:

• 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®.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerocrine AB: lead

Study Sites (13)

Olmstead Medical Center Byron

Byron, Minnesota, 55920, United States

Location

Olmstead Medical Center Chatfield

Chatfield, Minnesota, 55923, United States

Location

Olmstead Medical Center Pine Island

Pine Island, Minnesota, 55963, United States

Location

Olmstead Medical Center Plainview

Plainview, Minnesota, 55964, United States

Location

Olmstead Medical Center Preston

Preston, Minnesota, 55965, United States

Location

Olmstead Medical Center Northwest

Rochester, Minnesota, 55901, United States

Location

Olmstead Medical Center - Allergy Department

Rochester, Minnesota, 55904, United States

Location

Olmstead Medical Center - Family Medicine Department

Rochester, Minnesota, 55904, United States

Location

Olmsted Medical Center - Internal Medicine Department

Rochester, Minnesota, 55904, United States

Location

Olmstead Medical Center St. Charles

Saint Charles, Minnesota, 55972, United States

Location

Olmstead Medical Center Spring Valley

Spring Valley, Minnesota, 55975, United States

Location

Olmstead Medical Center Stewartville

Stewartville, Minnesota, 55976, United States

Location

Olmstead Medical Center Wanamingo

Wanamingo, Minnesota, 55983, United States

Location

MeSH Terms

Conditions

Asthma; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Physicians were blinded to FeNO results during the study, therefore asthma diagnoses and ICS prescriptions were made without knowledge of FeNO results.

Results Point of Contact

• Title: Nancy Herje
• Organization: Aerocrine, Inc.

Nancy.Herje@aerocrine.com

919-449-8873

Study Officials

• Nancy Herje, BSN, RN, MBA

  Aerocrine, Inc.

  STUDY DIRECTOR

• Barbara Yawn, MD, MSc

  Olmsted Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: January 26, 2012
• Study Start: November 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-06

Locations

US (13)