fenoTRACK monitoring of exhaled nitric oxide in children and adults with controlled and uncontrolled asthma

A Combined Prospective, Multicenter, Non-Randomized, Open-Label, Point-of-Care and Home Use Pivotal Study of the fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Non-Steroid-Treated Adult and Pediatric Uncontrolled Asthma Subjects and a Prospective Multicenter Clinical Precision Evaluation for Point-of-Care and Home Use in Adult and Pediatric Controlled Asthma Subjects

This test will see if the fenoTRACK device can track FeNO changes in people aged 5 and up with controlled or uncontrolled asthma, including whether FeNO falls after about two weeks of corticosteroids in uncontrolled patients.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 5 Years to 100 Years
• Sex: All
• Sponsor: Biometry Inc (Industry-sponsored)
• Drugs / interventions: omalizumab, dupilumab
• Locations: 13 sites (Stockton, California and 12 other locations)
• Trial ID: NCT07228026 on ClinicalTrials.gov

What this trial studies

This observational protocol enrolls two cohorts—uncontrolled and controlled asthma—and uses the fenoTRACK device to collect FeNO measurements at point-of-care and in a simulated at-home setting. Uncontrolled participants will have FeNO measured at Visit 1 and again at Visit 2 after an approximately two-week corticosteroid course to test for a clinically meaningful decline, with secondary outcomes including asthma control questionnaire scores, spirometry, and rescue medication use. Controlled participants will undergo repeated within-session FeNO measurements at both visits to determine the device's precision for point-of-care and home use. FeNO values from fenoTRACK will be compared to cleared FeNO devices and the number of attempts needed to obtain two valid readings will be recorded.

Who should consider this trial

Good fit: Ideal participants are children and adults aged 5 years and older with physician-diagnosed asthma who can perform FeNO maneuvers and, for the uncontrolled group, have elevated FeNO (≥30 ppb for adults or ≥25 ppb for those under 18) and agree to a short corticosteroid course.

Not a fit: Patients on chronic systemic corticosteroids, those with low baseline FeNO below the study thresholds, or those unable to produce reliable FeNO measurements are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, fenoTRACK could provide patients and clinicians a reliable way to monitor airway inflammation at home and adjust anti-inflammatory treatment sooner.

How similar studies have performed: Prior trials of FeNO-guided asthma management have shown benefit in guiding corticosteroid use and reducing exacerbations, but device-specific validation such as this remains necessary.

Eligibility criteria

Inclusion Criteria Uncontrolled Cohort:

1. The subject is male or female age 5 years and above
2. The subject and/or their Legally Authorized Representative (LAR) in the case of a minor has signed an Informed Consent Form (ICF) and Assent (as applicable per IRB requirements) and understands the risks and benefits of the study
3. The subject has a diagnosis of asthma
4. The subject is willing and able to perform all study procedures
5. The subject must have uncontrolled asthma as defined by the presence on at least 2 days per week (can be non-consecutive days) in the 7 days prior to V1 of at least 3 symptoms from the following list:

   i. Cough ii. Wheezing iii. Shortness of breath iv. Chest tightness v. Nocturnal awakening with asthma vi. Limitation in activity due to asthma
6. The subject has a FeNO value based on the first measurement of at least 30 ppb if an adult or at least 25 ppb if \<18 years old measured on a cleared FeNO device (e.g., NIOX VERO®)

Inclusion Criteria Controlled Cohort:

1. The subject is male or female age 5 years and above
2. The subject and/or their Legally Authorized Representative (LAR) in the case of a minor has signed an Informed Consent Form (ICF) and Assent (as applicable per IRB requirements) and understands the risks and benefits of the study
3. The subject has an established diagnosis of asthma for at least 180 days prior to V1
4. The subject is willing and able to perform all study procedures

Exclusion Criteria Uncontrolled:

1. The subject is in need of immediate referral to the emergency department
2. The subject has taken the following medications in the indicated period before V1:

   1. OCS within 4 weeks
   2. ICS within 2 weeks
   3. Biologic therapies (e.g., omalizumab or dupilumab) within 12 weeks. Note: Use of as needed ICS+SABA is also exclusionary in the 2 weeks prior to V1
3. The subject has a contraindication to corticosteroids.
4. The subject has demonstrated significant non-compliance during a previous clinical trial
5. The subject participated in any clinical study involving a drug, biologic, or device within 30 days prior to V1 or within 5 half-lives for drugs, whichever duration is shorter
6. The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis
7. Subject is an employee/relative of the following:

   1. Biometry Inc.
   2. Contract Research Organization(s) running the study
   3. Investigational Site
   4. Study Vendors
8. Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study
9. A ≥ 10 pack-year history of smoking or smoking in the 180 days prior to V1 (pack years = average packs/day x years of exposure) Note: smoking includes cigarettes, electronic cigarettes, cigars, and chewing or dipping tobacco
10. Pregnant or nursing subjects

Exclusion Criteria Controlled:

1. The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis
2. The subject has demonstrated significant non-compliance during a previous clinical trial
3. The subject participated in any clinical study involving a drug, biologic, or device within 30 days prior to V1 or within 5 half-lives for drugs, whichever duration is shorter.
4. Subject is an employee/relative of the following:

   1. Biometry Inc.
   2. Contract Research Organization(s) running the study
   3. Investigational Site
   4. Study Vendors
5. Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study
6. A ≥ 10 pack-year history of smoking or smoking in the 180 days prior to V1 (pack years = average packs/day x years of exposure) Note: smoking includes cigarettes, electronic cigarettes, cigars, and chewing or dipping tobacco
7. Pregnant or nursing subjects

Where this trial is running

Stockton, California and 12 other locations

• Bensch Clinical Research LLC — Stockton, California, United States (Recruiting)
• AllerVie Clinical Research — Panama City, Florida, United States (Active_not_recruiting)
• AllerVie Clinical Research — Columbus, Georgia, United States (Recruiting)
• Paul A Shapero MD — Bangor, Maine, United States (Recruiting)
• AllerVie Clinical Research — Ellicott City, Maryland, United States (Recruiting)
• AllerVie Clinical Research — Glenn Dale, Maryland, United States (Recruiting)
• Nebraska Medical Research Institute, Inc. — Bellevue, Nebraska, United States (Recruiting)
• Allergy Partners Clinical Research — Asheville, North Carolina, United States (Recruiting)
• Toledo Institute of Clinical Research Inc — Toledo, Ohio, United States (Recruiting)
• Orion Clinical Research — Austin, Texas, United States (Recruiting)
• Pharmaceutical Research & Consulting, Inc. — Dallas, Texas, United States (Recruiting)
• Western Sky Medical Research — El Paso, Texas, United States (Recruiting)
• Allergy, Asthma & Sinus Center, S.C. — Greenfield, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Philip E. Silkoff, MD — Precision ClinOps LLC
• Study coordinator: Vani Bhagwat, M.Sc.

Conditions Asthma; FeNO