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NCT01729247 · ClinicalTrials.gov registry record
Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age
A clinical trial of Asthma, sponsored by Aerocrine AB.
- Completed
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT01729247: Completed study of Asthma, sponsored by Aerocrine AB.
NCT01729247 is a study of Asthma that has completed, run by Aerocrine AB. The registered enrollment target is 50 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729247, a study of Asthma, has completed, sponsored by Aerocrine AB.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions. Secondary objectives: Evaluate the ability of physicians to correctly assess airway inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement). Estimate the cost consequences of changes in asthma management following FeNO determinations Number of participants: Approximately 40 to 50 subjects will participate in the study during an (approximately) 8-12 week study enrollment period. 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 (February, 2011). Response to Study Physician Questions before (Questions 1, 2, and 3) and after (Question 4) FeNO has been measured and seen by the Physician/Health Care Practitioner. 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 (CIP) from the time that informed consent has been provided and during the study period Criteria for evaluation: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may be used to design subsequent studies in subjects with asthma. Data collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing
Primary Outcome
Scores on an asthma control test (ACT) of \<=19 indicates less well controlled asthma, scores \>19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.
Conditions Studied
Interventions
- DEVICE NIOX MINO® Instrument (09-1100)
Study Locations (1)
North Carolina
- North Carolina Clinical Research - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-10 |
| Est. Completion | 2012-11 |
What the finished NCT01729247 record still lists
NCT01729247 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which NIOX MINO® Instrument (09-1100) is the first listed.
NCT01729247 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01729247 about?
NCT01729247 is a clinical study titled "Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age". Objective: To evaluate the impact of FeNO assessments on asthma treatment decisions. Secondary objectives: Evaluate the ability of physicians to correctly assess airway inflammation using standard clinical assessment tools (i.e., prior to FeNO measurement). Estimate the cost consequences of changes...
What is the current status of trial NCT01729247?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2012-10. Estimated completion is 2012-11.
What conditions does trial NCT01729247 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01729247?
The interventions under investigation include: NIOX MINO® Instrument (09-1100) (DEVICE).
Who is sponsoring clinical trial NCT01729247?
This trial is sponsored by Aerocrine AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01729247 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01729247's enrollment target sits among peer trials
50 263rd of 374 higher than 106 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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