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
Biometry Inc
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
Description
1. 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 contr…
Eligibility
- Age range
- 5–100 years
- Sex
- All
- Healthy volunteers
- No
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 l…
Interventions
- DevicefenoTRACK 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.
Locations (13)
- Bensch Clinical Research LLCStockton, California
- AllerVie Clinical ResearchPanama City, Florida
- AllerVie Clinical ResearchColumbus, Georgia
- Paul A Shapero MDBangor, Maine
- AllerVie Clinical ResearchEllicott City, Maryland
- AllerVie Clinical ResearchGlenn Dale, Maryland