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

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ClinicalTrials.gov Identifier: NCT01518322
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Sponsor:
Information provided by (Responsible Party):
Aerocrine AB

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Asthma
Intervention Device: NIOX MINO®
Enrollment 235
Recruitment Details The study was conducted at 5 primary care clinics in the US. First Subject Enrolled: 01Nov2011. Last Subject Completed 16Feb2012.
Pre-assignment Details 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.
Arm/Group Title FeNO
Hide Arm/Group Description All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Period Title: Overall Study
Started 235
Completed 222
Not Completed 13
Reason Not Completed
FeNO measurement was missing             13
Arm/Group Title FeNO
Hide Arm/Group Description All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
Overall Number of Baseline Participants 235
Hide Baseline Analysis Population Description
A total of 235 subjects were included in the All Subjects Population. 13 of the 235 subjects were missing the FeNO measurement.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants
<=18 years
21
   8.9%
Between 18 and 65 years
211
  89.8%
>=65 years
3
   1.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 235 participants
40.9  (14.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants
Female
155
  66.0%
Male
80
  34.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 235 participants
235
1.Primary Outcome
Title Relationship Between FeNO and the Diagnosis of Asthma
Hide Description 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.
Time Frame Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Low FeNO Intermediate FeNO High FeNO
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 98 42 22
Measure Type: Number
Unit of Measure: participants
1 1 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low FeNO, Intermediate FeNO, High FeNO
Comments Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Kappa Statistics
Estimated Value 0.0490
Confidence Interval (2-Sided) 95%
-0.0895 to 0.1875
Estimation Comments [Not Specified]
2.Primary Outcome
Title Relationship Between FeNO and the Prescription of ICS in Primary Care Practices
Hide Description 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.
Time Frame Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Low FeNO Intermediate FeNO High FeNO
Hide Arm/Group Description:
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.
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.
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
Overall Number of Participants Analyzed 98 42 22
Measure Type: Number
Unit of Measure: participants
5 1 0
3.Secondary Outcome
Title Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study
Hide Description The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.
Time Frame anytime prior to the single study visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Low FeNO Intermediate FeNO High FeNO
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 98 42 22
Measure Type: Number
Unit of Measure: participants
65 25 13
4.Post-Hoc Outcome
Title 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.
Hide Description 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.
Time Frame 4 to 6 months after the original study visit.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title High FeNO
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FeNO
Hide Arm/Group Description All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
All-Cause Mortality
FeNO
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
FeNO
Affected / at Risk (%)
Total   0/235 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FeNO
Affected / at Risk (%)
Total   0/235 (0.00%) 
Physicians were blinded to FeNO results during the study, therefore asthma diagnoses and ICS prescriptions were made without knowledge of FeNO results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nancy Herje
Organization: Aerocrine, Inc.
Phone: 919-449-8873
EMail: Nancy.Herje@aerocrine.com
Layout table for additonal information
Responsible Party: Aerocrine AB
ClinicalTrials.gov Identifier: NCT01518322    
Other Study ID Numbers: AER-040
First Submitted: November 11, 2011
First Posted: January 26, 2012
Results First Submitted: March 16, 2013
Results First Posted: August 30, 2013
Last Update Posted: August 30, 2013