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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.

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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

Conditions Studied

Interventions

  • DEVICE NIOX MINO® Instrument (09-1100)

Study Locations (1)

North Carolina

  • North Carolina Clinical Research - Raleigh

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-10
Est. Completion 2012-11

Sponsor

Aerocrine AB

5 total trials

What the Registry Record Tells You About NCT01729247

The ClinicalTrials.gov registry entry for NCT01729247 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The listed sponsor is Aerocrine AB, which has 5 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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