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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests fenoTRACK, a device that measures nitric oxide in breath (FeNO), in people age 5 and older with asthma. For uncontrolled asthma not treated with steroids, it checks whether FeNO drops after about 2 weeks of steroid treatment. For controlled asthma, it checks how closely repeated readings match at study visits and at home.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: You must be age 5 or older and have asthma.
  • Both groups: You or your legal representative must sign a consent form and understand the study’s risks and benefits. Children must also agree when required.
  • Both groups: You must be willing and able to do all study tasks.
  • Uncontrolled asthma group: In the week before visit 1, you must have at least 3 listed symptoms on at least 2 days: cough, wheezing, shortness of breath, chest tightness, waking at night from asthma, or activity limited by asthma.
  • Uncontrolled asthma group: Your first FeNO reading on an approved device must be at least 30 parts per billion for adults or 25 parts per billion for those under 18.
  • Controlled asthma group: Your asthma must have been diagnosed at least 180 days before visit 1.

Who can't join

  • Both groups: You have another major breathing condition, such as COPD (a long-term lung disease) or cystic fibrosis.
  • Both groups: You had major problems following the rules of an earlier clinical trial.
  • Both groups: You joined a drug, biologic, or device study within 30 days before visit 1. For drugs, a shorter period applies if 5 half-lives—the time for most of the drug to leave your body—is less than 30 days.
  • Both groups: You work for, or are related to someone at, Biometry Inc., the study site, a company running the study, or a study supplier.
  • Both groups: You used cigarettes, e-cigarettes, cigars, or chewing or dipping tobacco in the past 180 days, or have a smoking history of at least 10 pack-years. Pack-years means packs smoked per day times years smoked.
  • Both groups: You are pregnant or nursing, or the study doctor believes another condition makes joining unsuitable.
  • Uncontrolled asthma group only: You need emergency care right away or cannot safely take steroid medicines.
  • Uncontrolled asthma group only: Before visit 1, you took oral steroids within 4 weeks, inhaled steroids within 2 weeks, or biologic medicines such as omalizumab or dupilumab within 12 weeks. This includes an as-needed inhaler combining a steroid and a quick-relief medicine within 2 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (13)

CA

FL

GA

MD

ME

NC

NE

OH

TX

WI