Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
Recruiting · 13 sites across 10 states
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Your choice
Voluntary — you can stop anytime
What is 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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •People of any sex, age 5 years and older
- •Have a diagnosis of asthma
- •Be willing and able to do all study steps
- •For the uncontrolled group: have asthma symptoms on at least 2 days per week in the 7 days before Visit 1, with at least 3 symptoms from the list (cough, wheezing, shortness of breath, chest tightness, nighttime waking from asthma, or asthma limiting activity)
- •For the uncontrolled group: have an FeNO reading of at least 30 ppb (if an adult) or at least 25 ppb (if under 18) on the first measurement using a cleared FeNO device
🚫 You may not be able to join if…
- •Need immediate care and referral to the emergency department
- •Recent asthma medicines before Visit 1 (uncontrolled group): oral corticosteroids in the last 4 weeks, inhaled corticosteroids in the last 2 weeks, biologic therapies like omalizumab or dupilumab in the last 12 weeks; also, using as-needed ICS+SABA in the last 2 weeks
- •Cannot take corticosteroids (uncontrolled group)
- •Pregnant or nursing
- •Have significant non-compliance in a previous clinical trial, or took part in another drug/biologic/device study within 30 days (or within 5 drug half-lives, whichever is shorter)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 5–100
- ✓Have Asthma
- !Some conditions may not be a fit: COPD (chronic lung disease)
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT07228026 · Locations: California · Florida · Georgia · Maine · Maryland · Nebraska · North Carolina · Ohio · Texas · Wisconsin