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NCT01634620 · ClinicalTrials.gov registry record
Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease
A clinical trial, sponsored by Aerocrine AB.
- Completed
- Registry status
- 200
- Enrollment target
NCT01634620: Completed study, sponsored by Aerocrine AB.
NCT01634620 is a clinical trial that has completed, run by Aerocrine AB. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01634620 has completed, sponsored by Aerocrine AB.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease Number of participants: Approximately 200 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual 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 that informed consent has been provided and during the study period Criteria for evaluations: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design subsequent studies in patients with chronic obstructive airways disease. Information collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing
Primary Outcome
Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures t
Interventions
- DEVICE NIOX MINO® Instrument (09-1100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-10 |
What the finished NCT01634620 record still lists
NCT01634620 is an observational study that tracks outcomes without assigning an intervention. The registered 200 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® Instrument (09-1100) is the first listed.
NCT01634620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01634620 about?
NCT01634620 is a clinical study titled "Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease". Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease Number of participants: Approximately 200 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fr...
What is the current status of trial NCT01634620?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2012-06. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01634620?
The interventions under investigation include: NIOX MINO® Instrument (09-1100) (DEVICE).
Who is sponsoring clinical trial NCT01634620?
This trial is sponsored by Aerocrine AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
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