Trial Outcomes & Findings for Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms (NCT NCT01518322)

Results Overview

For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and \>35 ppb is high. For those aged 12 years or older, \<25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and \>50 ppb is high.

Recruitment status

COMPLETED

Target enrollment

235 participants

Primary outcome timeframe

Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)

Results posted on

2013-08-30

Participant Flow

The study was conducted at 5 primary care clinics in the US. First Subject Enrolled: 01Nov2011. Last Subject Completed 16Feb2012.

Following completion of the screening questionnaire that collected information about self-reported non-specific lower respiratory complaints such as cough, wheeze or shortness of breath, eligible subjects were invited to participate in the study.

Participant milestones

Participant milestones
Measure	FeNO All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Overall Study STARTED	235
Overall Study COMPLETED	222
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	FeNO All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Overall Study FeNO measurement was missing	13

Baseline Characteristics

Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FeNO n=235 Participants All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Age, Categorical <=18 years	21 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	211 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age Continuous	40.9 years STANDARD_DEVIATION 14.45 • n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Region of Enrollment United States	235 participants n=5 Participants

PRIMARY outcome

Timeframe: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)

Population: A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.

For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and \>35 ppb is high. For those aged 12 years or older, \<25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and \>50 ppb is high.

Outcome measures

Outcome measures
Measure	Low FeNO n=98 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low. For those aged 12 years or older, \<25 ppb is low.	Intermediate FeNO n=42 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.	High FeNO n=22 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, \>50 ppb is high. For children under age 12 years, \>35 ppb is high.
Relationship Between FeNO and the Diagnosis of Asthma	1 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)

Population: A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.

The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and \>35 ppb is high. For those aged 12 years or older, \<25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and \>50 ppb is high.

Outcome measures

Outcome measures
Measure	Low FeNO n=98 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low. For those aged 12 years or older, \<25 ppb is low.	Intermediate FeNO n=42 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.	High FeNO n=22 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, \>50 ppb is high. For children under age 12 years, \>35 ppb is high.
Relationship Between FeNO and the Prescription of ICS in Primary Care Practices	5 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: anytime prior to the single study visit

Population: A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.

The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.

Outcome measures

Outcome measures
Measure	Low FeNO n=98 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low. For those aged 12 years or older, \<25 ppb is low.	Intermediate FeNO n=42 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.	High FeNO n=22 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, \>50 ppb is high. For children under age 12 years, \>35 ppb is high.
Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study	65 participants	25 participants	13 participants

POST_HOC outcome

Timeframe: 4 to 6 months after the original study visit.

Population: Of the 162 subjects in the per-protocol population, 22 had a high FeNO (\>50ppb age 12 years and above; \>35ppb age less than 12 years). A retrospective medical record review was conducted and the number of subjects either diagnosed with asthma or treated with asthma medications is presented.

A medical record review of the 22 subjects with a high FeNO Value (\>50ppb age 12 years and above; \>35ppb age less than 12 years)during the original study visit was conducted. The number of subjects who were either diagnosed with asthma or treated with asthma medications is presented.

Outcome measures

Outcome measures
Measure	Low FeNO n=22 Participants Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, \<20 ppb is low. For those aged 12 years or older, \<25 ppb is low.	Intermediate FeNO Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.	High FeNO Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, \>50 ppb is high. For children under age 12 years, \>35 ppb is high.
Of the 22 Subjects With a High FeNO (>50ppb Age 12 Years and Above; >35ppb Age Less Than 12 Years)During the Original Study Visit, Number of Subjects Subsequently Treated With Asthma Medications or Diagnosed With Asthma.	5 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

Aerocrine, Inc.

Phone: 919-449-8873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60