RecruitingAsthma

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

Eligible age

5–100 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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

Sponsor: Biometry Inc

You may qualify if…

✓ 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®)
✓ 1. The subject is male or female age 5 years and above

You may not qualify if…

✕ 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