Tracking Breath Nitric Oxide with a Device in Asthma

Trial details

Who runs it

Biometry Inc

Trial code

NCT07228026

Record updated

2 June 2026

Original description

This study incorporates objectives directed at two subject cohorts:Read full original descriptionShow less

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 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

Inclusion: 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:; 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.

Exclusion: The subject has taken the following medications in the indicated period before V1:; OCS within 4 weeks; ICS within 2 weeks; 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; 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; 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; 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; 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; The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis; Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study; The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis; Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study; The subject is in need of immediate referral to the emergency department; Subject is an employee/relative of the following:; Biometry Inc; Contract Research Organization(s) running the study; Investigational Site; Study Vendors; Pregnant or nursing subjects; Subject is an employee/relative of the following:; Biometry Inc; Contract Research Organization(s) running the study; Investigational Site; Study Vendors; Pregnant or nursing subjects.

ClinicalTrials.gov NCT07228026