60
*3 subjects in the clinical precision study had a large variation between the measurements. 1 subject
was from median concentration bin of >= 50 ppb and 2 subjects were from the median
concentration bin of 40 to <50 ppb. The %CV for these subjects was 10.24%, 21.54%, and 14.17%.
This table excludes data from these three subjects.
There were no adverse events, serious injuries, issues or problems with use of the NObreath in
participants.
Study 2: A clinical study illustrating asthma patient response to anti-inflammatory therapy using
the FeNObreath™.
A second study also evaluated the clinical efficacy of the FeNObreath™;
A total of 186 patients (n= 95 18+ and n=91 7 to 17 years of age) participated in a longitudinal study
where measurements for FeNO, spirometry, and asthma control questionnaires were completed at
baseline (Visit 1) and two weeks later (Visit 2) after therapeutic agents were administered.
For those with elevated initial FeNO defined by ATS >25ppb for adults and >20ppb for children (total
n=139),there was a fall in mean FeNO measured by FeNObreath™ in patients with elevated FeNO
levels for combined adult and pediatric treatment population (n=139).
Results showed a mean change of -13.7ppb (-27.7%) with a mean SD of 17.8.
The Decline in FeNO was accompanied by the following changes in subjective and objective
asthma measures.
The following secondary outcome measures showed the following after 2 weeks of corticosteroid
therapy that accompanied the fall in FeNO described above.
ACQ:
Mean ACQ score fell by -29.7% after corticosteroids
FEV1:
There was a mean FEV1 change of 10.1% after corticosteroids
References:
1.
An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels
(FeNO) for Clinical Applications | American Journal of Respiratory and Critical Care Medicine
[Internet]. Atsjournals.org. 2021 [cited 21 July 2021]. Available from:
https://www.atsjournals.org/doi/full/10.1164/rccm.9120-11ST
2.
Asthma Control Questionnaire (ACQ) [Internet]. Thoracic.org. 2021 [cited 21 July 2021].
Available from:
https://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php
3.
Minimal Clinically Important Differences in Pharmacological Trials [Internet]. Atsjournals.org.
2021 [cited 21 July 2021]. Available from:
