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NCT01648920 · ClinicalTrials.gov registry record
A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma
A clinical trial, sponsored by Aerocrine AB.
- Completed
- Registry status
- 50
- Enrollment target
NCT01648920: Completed study, sponsored by Aerocrine AB.
NCT01648920 is a clinical trial that has completed, run by Aerocrine AB. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648920 has completed, sponsored by Aerocrine AB.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed asthma Number of participants: Approximately 50 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: FeNO measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual. MCC testing will be performed according to the ATS guidelines and the allergy and asthma specialists procedure for conducting MCC tests 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 exploratory study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design and power subsequent studies in patients with suspected but undiagnosed asthma. Information collected will be summarized in a clinical study report
Primary Outcome
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 (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis.
Interventions
- DEVICE NIOX MINO® Instrument (09-1100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-11 |
What the finished NCT01648920 record still lists
NCT01648920 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which NIOX MINO® Instrument (09-1100) is the first listed.
NCT01648920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01648920 about?
NCT01648920 is a clinical study titled "A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma". Objective: To explore the utility of Fractional Exhaled Nitric Oxide (FeNO) compared with Methacholine Challenge (MCC) testing in assessing patients with suspected but undiagnosed asthma Number of participants: Approximately 50 subjects will be enrolled Reference product: NIOX MINO® Instrument (09...
What is the current status of trial NCT01648920?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01648920?
The interventions under investigation include: NIOX MINO® Instrument (09-1100) (DEVICE).
Who is sponsoring clinical trial NCT01648920?
This trial is sponsored by Aerocrine AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
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