Recruiting

Corticosteroid Therapy

Sponsor:

Biometry Inc

Code:

NCT07228026

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

fenoTRACK Device

Study Details

Brief summary:

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

Asthma

Study ID

NCT07228026

Start date

Sep 17, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Uncontrolled Asthma Subjects

fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects

Controlled Asthma Subjects

fenoTRACK for Controlled Adult and Pediatric Asthma Subjects

Interventions

fenoTRACK 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.

Primary outcome measure

  • Uncontrolled Cohort - Magnitude of change in FeNO Values [ Time Frame: Visit 2 (Day 14) ]

Central Contacts and Locations

Locations

Bensch Clinical Research LLC

Recruiting

Stockton, California, United States, 95207

Contacts

AllerVie Clinical Research

Recruiting

Panama City, Florida, United States, 32405

Contacts

AllerVie Clinical Research

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Paul A Shapero MD

Recruiting

Bangor, Maine, United States, 04401

Contacts

AllerVie Clinical Research

Recruiting

Ellicott City, Maryland, United States, 21043

Contacts

AllerVie Clinical Research

Recruiting

Glenn Dale, Maryland, United States, 20769

Contacts

Nebraska Medical Research Institute, Inc.

Recruiting

Bellevue, Nebraska, United States, 68123-4303

Contacts

Allergy Partners Clinical Research

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Toledo Institute of Clinical Research Inc

Recruiting

Toledo, Ohio, United States, 43617

Contacts

Orion Clinical Research

Recruiting

Austin, Texas, United States, 78759

Contacts

Pharmaceutical Research & Consulting, Inc.

Recruiting

Dallas, Texas, United States, 75231

Contacts

Western Sky Medical Research

Recruiting

El Paso, Texas, United States, 79912

Contacts

Allergy, Asthma & Sinus Center, S.C.

Recruiting

Greenfield, Wisconsin, United States, 53228

Contacts

Jennifer Kuhl

jkuhl@myaasc.com

More Information

Sponsor

Biometry Inc

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Asthma
  • FeNO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biometry Inc on 2026-06-02.