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NCT01518322 · ClinicalTrials.gov registry record
Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms
A clinical trial, sponsored by Aerocrine AB.
- Completed
- Registry status
- 235
- Enrollment target
NCT01518322: Completed study, sponsored by Aerocrine AB.
NCT01518322 is a clinical trial that has completed, run by Aerocrine AB. The registered enrollment target is 235 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01518322 has completed, sponsored by Aerocrine AB.
- COMPLETED
- Registry status
- 235 participants
- Enrollment target
Study 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.
Primary Outcome
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, \<2
Interventions
- DEVICE NIOX MINO®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-02 |
What the finished NCT01518322 record still lists
NCT01518322 is an observational study that tracks outcomes without assigning an intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which NIOX MINO® is the first listed.
NCT01518322 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01518322 about?
NCT01518322 is a clinical study titled "Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms". 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 pre...
What is the current status of trial NCT01518322?
This trial is currently completed. The enrollment target is 235 participants. The study started on 2011-11. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01518322?
The interventions under investigation include: NIOX MINO® (DEVICE).
Who is sponsoring clinical trial NCT01518322?
This trial is sponsored by Aerocrine AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
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