AsthmaNCT07228026
Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
An observational study of Asthma, run by Biometry Inc at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- fenoTRACK Device
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 13 sitesUnited States
- Study dates
- 17 Sep 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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.
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- 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
- Pregnant or nursing subjects
- The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis
- 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.
- 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
- Pregnant or nursing subjects
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Allergy Partners Clinical Research
Asheville, North Carolina, 28803
Karen Murdock, khmurdock@allergypartners.com
- Recruiting
Orion Clinical Research
Austin, Texas, 78759
Faye Nunnelee, sfnunnelee@orionclinicalresearch.com
- Recruiting
Paul A Shapero MD
Bangor, Maine, 04401
Michelle Doucette, studycenter@evergreendocs.com
- Recruiting
Nebraska Medical Research Institute, Inc.
Bellevue, Nebraska, 68123-4303
Wendy Paulson, wpaulson@asthmaandallergycenter.com
- Recruiting
AllerVie Clinical Research
Columbus, Georgia, 31904
Matti Sherer, msherer@allervie.com
- Recruiting
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231
Katrina Goldie, katrina.goldie@daac-prc.com
- Recruiting
Western Sky Medical Research
El Paso, Texas, 79912
Karen Pinon, Kpinon@westernskymed.com
- Recruiting
AllerVie Clinical Research
Ellicott City, Maryland, 21043
Chase Nichols, cnichols@allervie.com
- Recruiting
AllerVie Clinical Research
Glenn Dale, Maryland, 20769
Chase Nichols, cnichols@allervie.com
- Recruiting
Allergy, Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, 53228
Jennifer Kuhl, jkuhl@myaasc.com
- Recruiting
AllerVie Clinical Research
Panama City, Florida, 32405
Lauren Green, lgreen@allervie.com
- Recruiting
Bensch Clinical Research LLC
Stockton, California, 95207
Tara Clary, 209-951-6741, tarclry@aol.com
- Recruiting
Toledo Institute of Clinical Research Inc
Toledo, Ohio, 43617
Faheem Husain, faheem.husain@ohmiallergy.com
About this study
Official title: 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:
- 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.
- 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
Read the detailed description
- Uncontrolled Adult and Pediatric Asthma Subjects The primary objective is: To demonstrate a statistically significant and clinically meaningful decline in POC FeNO as measured by the fenoTRACK device from Visit 1 (V1) to Visit 2 (V2), after an approximately 2-week course of corticosteroid therapy in adults and children with non-steroid treated uncontrolled asthma. Secondary objectives:
- To demonstrate that the decline in FeNO on the fenoTRACK device is accompanied by improvements in asthma outcome measures including the 7-item asthma control questionnaire (ACQ) score or asthma control questionnaire - Interviewer Administered (ACQ-IA), lung function as assessed by spirometry, and rescue medication use
- To demonstrate clinical accuracy of FeNO measurements on the fenoTRACK device by comparison of within-session FeNO values acquired in a simulated at home FeNO versus FeNO values acquired at the POC at V1 and V2
- To record how many efforts are required to achieve 2 valid FeNO results on the fenoTRACK device for simulated at home FeNO and POC FeNO measurements at V1 and V2, and between V1 and V2
- Controlled Adult and Pediatric Asthma Subjects
Co-primary objectives:
- To evaluate within-session clinical precision during V1 and V2 for the fenoTRACK device for simulated at home FeNO, and at POC To evaluate within-session clinical precision for home fenoTRACK use Secondary objectives:To demonstrate clinical accuracy of FeNO measurements on the fenoTRACK device by comparison of within-session FeNO values acquired for simulated at home FeNO versus FeNO values acquired at the POC at V1 and V2
- To record how many efforts are required to achieve 2 valid FeNO results on the fenoTRACK device for simulated at home FeNO and POC measurements at V1 and V2, and between V1 and V2
- Conditions
- Asthma
- Being tested
- fenoTRACK Device
- Keywords
- Asthma, FeNO
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenoTRACK DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Uncontrolled Asthma Subjects | fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects Receives: Device: fenoTRACK Device | |
| Controlled Asthma Subjects | fenoTRACK for Controlled Adult and Pediatric Asthma Subjects Receives: Device: fenoTRACK Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 2 (Day 14)
Secondary outcomes (6)
Uncontrolled Cohort - Magnitude of change (POC)
Magnitude of change expressed both as absolute and percentage change, in POC FeNO values using the fenoTRACK device in the uncontrolled cohort.
Measured: Visit 2 (Day 14)
Uncontrolled Cohort - Magnitude of change (Home Use)
Uncontrolled Cohort - Magnitude of change expressed both as absolute and percentage change, in actual at home using the fenoTRACK device in the uncontrolled cohort.
Measured: 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
The changes in 7-item ACQ/ACQ-IA Scores for both questionnaires from V1 to V2 will be estimated in the uncontrolled Cohort
Measured: Visit 2 (Day 14)
Uncontrolled Cohort - Change in best spirometry measures
Change in best spirometry measures, both absolute and percent, Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), FEV1/FVC in the uncontrolled cohort.
Measured: 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
Precision is assessed by evaluating the statistical repeatability of two exhaled nitric oxide (FeNO) measurements which are measured by the fenoTRACK investigational device in parts per billion. This will be assessed at Visit 1 and Visit 2 using the Simulated at home, POC and at home setting in the controlled cohort.
Measured: Visit 2 (Day 14)
Controlled cohort - Accuracy of FeNO results by comparison of paired within-individual FeNO values acquired in a simulated home-use environment versus FeNO values acquired at the POC at both V1 and V2
Accuracy for a diagnostic measure means that the FeNO values in parts per billion measured by the fenoTRACK investigational device will be compared statistically between the simulated at home i.e. independently acquired measures and the POC measures obtained under supervision in the clinic. Accuracy is expressed as a correlation value and confidence limits for the correlation between the two measures in the controlled cohort.
Measured: Visit 2 (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start17 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biometry Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip E. Silkoff, MD, Principal investigator, Precision ClinOps LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228026
- Sponsor's protocol ID
- F1
- Status last verified
- May 2026
- First submitted
- 27 Oct 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07228026
- Acronym / sponsor ID
- F1
- Conditions
- Asthma
- Keywords
- Asthma, FeNO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Biometry IncIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study incorporates objectives directed at two subject cohorts:
- 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.
- 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
Detailed description
- Uncontrolled Adult and Pediatric Asthma Subjects The primary objective is: To demonstrate a statistically significant and clinically meaningful decline in POC FeNO as measured by the fenoTRACK device from Visit 1 (V1) to Visit 2 (V2), after an approximately 2-week course of corticosteroid therapy in adults and children with non-steroid treated uncontrolled asthma. Secondary objectives:
- To demonstrate that the decline in FeNO on the fenoTRACK device is accompanied by improvements in asthma outcome measures including the 7-item asthma control questionnaire (ACQ) score or asthma control questionnaire - Interviewer Administered (ACQ-IA), lung function as assessed by spirometry, and rescue medication use
- To demonstrate clinical accuracy of FeNO measurements on the fenoTRACK device by comparison of within-session FeNO values acquired in a simulated at home FeNO versus FeNO values acquired at the POC at V1 and V2
- To record how many efforts are required to achieve 2 valid FeNO results on the fenoTRACK device for simulated at home FeNO and POC FeNO measurements at V1 and V2, and between V1 and V2
- Controlled Adult and Pediatric Asthma Subjects
Co-primary objectives:
- To evaluate within-session clinical precision during V1 and V2 for the fenoTRACK device for simulated at home FeNO, and at POC To evaluate within-session clinical precision for home fenoTRACK use Secondary objectives:To demonstrate clinical accuracy of FeNO measurements on the fenoTRACK device by comparison of within-session FeNO values acquired for simulated at home FeNO versus FeNO values acquired at the POC at V1 and V2
- To record how many efforts are required to achieve 2 valid FeNO results on the fenoTRACK device for simulated at home FeNO and POC measurements at V1 and V2, and between V1 and V2
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncontrolled Asthma Subjects | – | Device: fenoTRACK DevicefenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects |
| Controlled Asthma Subjects | – | Device: fenoTRACK DevicefenoTRACK for Controlled Adult and Pediatric Asthma Subjects |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (28 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenoTRACK DeviceHome 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. | Device | Controlled Asthma Subjects, Uncontrolled Asthma Subjects |
Primary outcome
Uncontrolled Cohort - Magnitude of change in FeNO Values
Time frame: Visit 2 (Day 14)
Magnitude of change, expressed both as absolute and percentage change in FeNO values in the uncontrolled cohort from Visit 1 to Visit 2.
6 secondary outcomes
Uncontrolled Cohort - Magnitude of change (POC)
Time frame: Visit 2 (Day 14)
Uncontrolled Cohort - Magnitude of change (Home Use)
Time frame: 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
Time frame: Visit 2 (Day 14)
Uncontrolled Cohort - Change in best spirometry measures
Time frame: 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
Time frame: Visit 2 (Day 14)
Controlled cohort - Accuracy of FeNO results by comparison of paired within-individual FeNO values acquired in a simulated home-use environment versus FeNO values acquired at the POC at both V1 and V2
Time frame: Visit 2 (Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip E. Silkoff, MD principal investigator
Precision ClinOps LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Biometry Inc at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vani Bhagwat, M.Sc. (647-331-4256, vbhagwat@precisionclinops.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncontrolled Cohort - Magnitude of change in FeNO Values (time frame: Visit 2 (Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.