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Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age

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ClinicalTrials.gov Identifier: NCT01729247
Recruitment Status : Completed
First Posted : November 20, 2012
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB

Brief 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


Condition or disease Intervention/treatment
Asthma Device: NIOX MINO® Instrument (09-1100)

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : October 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Group/Cohort Intervention/treatment
FeNO
Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
Device: NIOX MINO® Instrument (09-1100)



Primary Outcome Measures :
  1. FeNO Values by ACT Score [ Time Frame: Study Visit (single visit study). Approximately 1 hour. ]
    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.

  2. FeNO Categorical Levels by ICS Use [ Time Frame: Study visit (single visit study). Approximately1 hour. ]
    Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.


Secondary Outcome Measures :
  1. Physician Assessment of Airway Inflammation [ Time Frame: Study visit (single visit study) approximately 1 hour ]
    Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).

  2. Number of Participants Correctly Categorized by True Level of Airway Inflammation [ Time Frame: Study visit (single visit study) approximately 1 hour. ]
    Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.

  3. Asthma Management Changes After FeNO Results Were Considered [ Time Frame: Study visit (single visit study). Approximately1 hour. ]
    Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).



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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects, 7 to 60 years of age, inclusive, with asthma will be recruited
Criteria

Inclusion Criteria:

  • Age: 7 to 60 years of age, inclusive
  • Sex: Males and Females
  • Diagnosis: Asthma

Exclusion Criteria:

  • Concurrent Conditions or Disease: Subjects with an established diagnosis of chronic, obstructive pulmonary disease (COPD) cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, or vocal cord dysfunction are excluded from participation
  • Cigarette Smoking: Subjects with greater than a 10 pack-year history of cigarette smoking are excluded from participation
  • Study Participation Outside of This Protocol: Subjects currently enrolled in studies of Investigational or Non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded from participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729247


Locations
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
Aerocrine AB

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01729247     History of Changes
Other Study ID Numbers: AER-043
First Posted: November 20, 2012    Key Record Dates
Results First Posted: March 3, 2014
Last Update Posted: March 3, 2014
Last Verified: January 2014

Keywords provided by Aerocrine AB:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases