Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects

NCT07228026 | Recruiting

• 1 other identifier: F1
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 13

Brief Summary

This study incorporates objectives directed at two subject cohorts:

• 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

Asthma

Keywords

Asthma; FeNO

Outcome Measures

Primary Outcomes (1)

• Uncontrolled Cohort - Magnitude of change in FeNO Values

  Magnitude of change, expressed both as absolute and percentage change in FeNO values in the uncontrolled cohort from Visit 1 to Visit 2.

  Visit 2 (Day 14)

Secondary Outcomes (6)

• Uncontrolled Cohort - Magnitude of change (POC)

  Visit 2 (Day 14)

• Uncontrolled Cohort - Magnitude of change (Home Use)

  Day 1 and Day 2 AM and PM FeNO values compared to average of the last 2 Days prior to Visit 2

• Uncontrolled Cohort - Change in 7-item ACQ/ACQ-IA

  Visit 2 (Day 14)

• Uncontrolled Cohort - Change in best spirometry measures

  Visit 2 (Day 14)

• Controlled cohort - Clinical precision based on the first 2 FeNO results - Within-session clinical precision in a simulated home-use environment (V1 and V2) - Within-session clinical precision at the POC (V1 and V2) - Clinical precision at home

  Visit 2 (Day 14)

Study Arms (2)

Uncontrolled Asthma Subjects

fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects

Device: fenoTRACK Device

Controlled Asthma Subjects

fenoTRACK for Controlled Adult and Pediatric Asthma Subjects

Device: fenoTRACK Device

Interventions

fenoTRACK Device DEVICE

Home FeNO Monitoring: FeNO measurement will be performed. POC Longitudinal Response to Treatment: FeNO measurement will be performed in the office both the simulated home environment and POC environment.

Controlled Asthma Subjects; Uncontrolled Asthma Subjects

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes two distinct cohorts. The first cohort comprises male and female subjects aged 5 and above with uncontrolled asthma (See uncontrolled Asthma subject Inclusion Criteria). The second cohort comprises male and female subjects aged 5 and above with controlled asthma. If one of the subject cohorts completes before the other, the Sponsor reserves the right to analyze that cohort first.

You may qualify if:

• The subject is male or female age 5 years and above
• 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
• The subject has a diagnosis of asthma
• The subject is willing and able to perform all study procedures
• 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
• 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®)
• The subject is male or female age 5 years and above
• 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
• The subject has an established diagnosis of asthma for at least 180 days prior to V1
• The subject is willing and able to perform all study procedures

You may not qualify if:

• The subject is in need of immediate referral to the emergency department
• The subject has taken the following medications in the indicated period before V1:
• OCS within 4 weeks
• ICS within 2 weeks
• The subject has a contraindication to corticosteroids.
• The subject has demonstrated significant non-compliance during a previous clinical trial
• 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
• The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis
• Subject is an employee/relative of the following:
• Biometry Inc.
• Contract Research Organization(s) running the study
• Investigational Site
• Study Vendors
• Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study
• 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

Sponsors & Collaborators

• Biometry Inc: lead

Study Sites (13)

Bensch Clinical Research LLC

Stockton, California, 95207, United States

RECRUITING

AllerVie Clinical Research

Panama City, Florida, 32405, United States

ACTIVE NOT RECRUITING

AllerVie Clinical Research

Columbus, Georgia, 31904, United States

RECRUITING

Paul A Shapero MD

Bangor, Maine, 04401, United States

RECRUITING

AllerVie Clinical Research

Ellicott City, Maryland, 21043, United States

RECRUITING

AllerVie Clinical Research

Glenn Dale, Maryland, 20769, United States

RECRUITING

Nebraska Medical Research Institute, Inc.

Bellevue, Nebraska, 68123-4303, United States

RECRUITING

Allergy Partners Clinical Research

Asheville, North Carolina, 28803, United States

RECRUITING

Toledo Institute of Clinical Research Inc

Toledo, Ohio, 43617, United States

RECRUITING

Orion Clinical Research

Austin, Texas, 78759, United States

RECRUITING

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, 75231, United States

RECRUITING

Western Sky Medical Research

El Paso, Texas, 79912, United States

RECRUITING

Allergy, Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, 53228, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Philip E. Silkoff, MD

  Precision ClinOps LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vani Bhagwat, M.Sc.

CONTACT

647-331-4256; vbhagwat@precisionclinops.com

Ming Lee, B.Sc.

CONTACT

647-533-8001; mlee@precisionclinops.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: November 13, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)