Trial Outcomes & Findings for Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age (NCT NCT01729247)

Last Updated: 2014-03-03

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Study Visit (single visit study). Approximately 1 hour.

Results posted on

2014-03-03

Participant Flow

Participants expressing interest who met inclusion and exclusion criteria were asked to sign written informed consent prior to participation.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FeNO n=50 Participants 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.
Age, Continuous	35.1 years STANDARD_DEVIATION 15.81 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Smoking Status Never Smoked	35 participants n=5 Participants
Smoking Status Current Smoker	0 participants n=5 Participants
Smoking Status Past Smoker	15 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions SABA	47 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions ICS/LABA Combination	20 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions H1-Receptor Antagonist	17 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions ICS	10 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions Antihistamine	9 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions Intranasal Corticosteroid	9 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions Leukotriene Receptor Antagonist	8 participants n=5 Participants
Current Medications used for Pulmonary and/or Allergy Conditions Nasal Decongestant	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Study Visit (single visit study). Approximately 1 hour.

Outcome measures

Outcome measures
Measure	Low ACT Score n=29 Participants Participants who had an asthma control test (ACT) score of \<=19, which indicates less well-controlled asthma	High ACT Score n=21 Participants Participants who had an asthma control test (ACT) score of \>19, which indicates well-controlled asthma	High Airway Inflammation As categorized by physician assessment
FeNO Values by ACT Score	40.3 parts per billion (ppb) Standard Deviation 50.84	26.3 parts per billion (ppb) Standard Deviation 21.42	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Low ACT Score n=29 Participants Participants who had an asthma control test (ACT) score of \<=19, which indicates less well-controlled asthma	High ACT Score n=21 Participants Participants who had an asthma control test (ACT) score of \>19, which indicates well-controlled asthma	High Airway Inflammation As categorized by physician assessment
FeNO Categorical Levels by ICS Use Low FeNO	18 participants	11 participants	—
FeNO Categorical Levels by ICS Use Intermediate FeNO	6 participants	4 participants	—
FeNO Categorical Levels by ICS Use High FeNO	5 participants	6 participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Low ACT Score n=34 Participants Participants who had an asthma control test (ACT) score of \<=19, which indicates less well-controlled asthma	High ACT Score n=14 Participants Participants who had an asthma control test (ACT) score of \>19, which indicates well-controlled asthma	High Airway Inflammation n=2 Participants As categorized by physician assessment
Physician Assessment of Airway Inflammation	31.4 parts per billion (ppb) Standard Deviation 38.16	40.6 parts per billion (ppb) Standard Deviation 51.37	42.0 parts per billion (ppb) Standard Deviation 25.46

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Low ACT Score n=29 Participants Participants who had an asthma control test (ACT) score of \<=19, which indicates less well-controlled asthma	High ACT Score n=10 Participants Participants who had an asthma control test (ACT) score of \>19, which indicates well-controlled asthma	High Airway Inflammation n=11 Participants As categorized by physician assessment
Number of Participants Correctly Categorized by True Level of Airway Inflammation	21 participants correctly categorized	3 participants correctly categorized	1 participants correctly categorized

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Low ACT Score n=50 Participants Participants who had an asthma control test (ACT) score of \<=19, which indicates less well-controlled asthma	High ACT Score Participants who had an asthma control test (ACT) score of \>19, which indicates well-controlled asthma	High Airway Inflammation As categorized by physician assessment
Asthma Management Changes After FeNO Results Were Considered No Changes	32 participants	—	—
Asthma Management Changes After FeNO Results Were Considered Changes to SABA	9 participants	—	—
Asthma Management Changes After FeNO Results Were Considered Changes to ICS	8 participants	—	—
Asthma Management Changes After FeNO Results Were Considered Changes to ICS/LABA Combination	6 participants	—	—
Asthma Management Changes After FeNO Results Were Considered Changes to LTRA	2 participants	—	—

Adverse Events

FeNO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Herje, BSN, RN, MBA

Aerocrine, Inc.

Phone: 919-449-8873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place