Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms
This study has been completed.
Sponsor:
Aerocrine AB
Information provided by (Responsible Party):
Aerocrine AB
ClinicalTrials.gov Identifier:
NCT01518322
First received: November 11, 2011
Last updated: May 23, 2012
Last verified: May 2012
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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 and percentage of subjects diagnosed with asthma will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO will be dichotimized into high and low categories and the associated kappa statistics and 95% confidence intervals will be presented. FeNO dichotomization will be calculated per the American Thoracic Society (ATS) standards above and below 200 ppb for subjects <12 years old, and above and below 25 ppb for subjects >=12 years old.
- 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 and percentage of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO will be summarized as a continuous variable by ICS prescribed (yes/no) and asthma diagnosis (yes/no) will be displayed.
Secondary Outcome Measures:
- Summary of Cough, Wheeze, and SOB Episodes During the 24 Months Prior to Study [ Time Frame: 24 months prior to the single study visit ] [ Designated as safety issue: No ]A medical record review of clinic visits that occurred 24 months prior to the study visit. The total number of similar episodes of cough, wheeze, and shortness of breath (SOB) will be summarized.
| 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
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 |
| Last Updated: | May 23, 2012 |
| 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 Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013