Actively Recruiting
Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
Led by Biometry Inc · Updated on 2026-03-24
160
Participants Needed
13
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study incorporates objectives directed at two subject cohorts: 1. Uncontrolled Adult and Pediatric Asthma Subjects: To demonstrate a statistically significant and clinically meaningful decline in Point Of Care (POC) FeNO as measured by the fenoTRACK device, after an approximately 2-week course of corticosteroid therapy in adults and children with non-steroid treated uncontrolled asthma. 2. Controlled Adult and Pediatric Asthma Subjects: * To evaluate within-session clinical precision during Visit 1 and Visit 2 for the fenoTRACK device for simulated at home FeNO, and at POC * To evaluate within-session clinical precision for home fenoTRACK use
CONDITIONS
Official Title
Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 5 years and above
- Signed informed consent and assent as applicable
- Diagnosis of asthma
- Willing and able to perform all study procedures
- For uncontrolled asthma group: asthma symptoms on at least 2 days per week during the 7 days prior to Visit 1 with at least 3 symptoms from cough, wheezing, shortness of breath, chest tightness, nocturnal awakening, or activity limitation
- For uncontrolled asthma group: FeNO value of at least 30 ppb if adult or at least 25 ppb if under 18 years on a cleared FeNO device
- For controlled asthma group: established asthma diagnosis for at least 180 days prior to Visit 1
You will not qualify if you...
- Need for immediate emergency department referral
- Use of oral corticosteroids within 4 weeks prior to Visit 1
- Use of inhaled corticosteroids within 2 weeks prior to Visit 1
- Use of biologic therapies within 12 weeks prior to Visit 1
- Contraindication to corticosteroids
- Significant non-compliance in a previous clinical trial
- Participation in another clinical study involving drug, biologic, or device within 30 days or 5 half-lives prior to Visit 1
- Other significant respiratory conditions such as COPD or cystic fibrosis
- Employment or relation to Biometry Inc., contract research organizations, investigational sites, or study vendors
- Any condition making participation undesirable according to the investigator
- History of smoking 10 or more pack-years or smoking in the 180 days prior to Visit 1
- Pregnancy or nursing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Bensch Clinical Research LLC
Stockton, California, United States, 95207
Actively Recruiting
2
AllerVie Clinical Research
Panama City, Florida, United States, 32405
Active, Not Recruiting
3
AllerVie Clinical Research
Columbus, Georgia, United States, 31904
Actively Recruiting
4
Paul A Shapero MD
Bangor, Maine, United States, 04401
Actively Recruiting
5
AllerVie Clinical Research
Ellicott City, Maryland, United States, 21043
Actively Recruiting
6
AllerVie Clinical Research
Glenn Dale, Maryland, United States, 20769
Actively Recruiting
7
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, United States, 68123-4303
Actively Recruiting
8
Allergy Partners Clinical Research
Asheville, North Carolina, United States, 28803
Actively Recruiting
9
Toledo Institute of Clinical Research Inc
Toledo, Ohio, United States, 43617
Actively Recruiting
10
Orion Clinical Research
Austin, Texas, United States, 78759
Actively Recruiting
11
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, United States, 75231
Actively Recruiting
12
Western Sky Medical Research
El Paso, Texas, United States, 79912
Actively Recruiting
13
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
Research Team
V
Vani Bhagwat, M.Sc.
CONTACT
M
Ming Lee, B.Sc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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