Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms
Public ClinicalTrials.gov record NCT01518322. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01518322
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 235 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2011
- Primary completion
- Jan 31, 2012
- Completion
- Jan 31, 2012
- Last update posted
- Aug 29, 2013
2011 – 2012
United States locations
- U.S. sites
- 13
- U.S. states
- 1
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Olmstead Medical Center Byron | Byron | Minnesota | 55920 | — |
| Olmstead Medical Center Chatfield | Chatfield | Minnesota | 55923 | — |
| Olmstead Medical Center Pine Island | Pine Island | Minnesota | 55963 | — |
| Olmstead Medical Center Plainview | Plainview | Minnesota | 55964 | — |
| Olmstead Medical Center Preston | Preston | Minnesota | 55965 | — |
| Olmstead Medical Center Northwest | Rochester | Minnesota | 55901 | — |
| Olmstead Medical Center - Allergy Department | Rochester | Minnesota | 55904 | — |
| Olmstead Medical Center - Family Medicine Department | Rochester | Minnesota | 55904 | — |
| Olmsted Medical Center - Internal Medicine Department | Rochester | Minnesota | 55904 | — |
| Olmstead Medical Center St. Charles | Saint Charles | Minnesota | 55972 | — |
| Olmstead Medical Center Spring Valley | Spring Valley | Minnesota | 55975 | — |
| Olmstead Medical Center Stewartville | Stewartville | Minnesota | 55976 | — |
| Olmstead Medical Center Wanamingo | Wanamingo | Minnesota | 55983 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01518322, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01518322 live on ClinicalTrials.gov.