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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:
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:
Controlled Adult and Pediatric Asthma Subjects
Co-primary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncontrolled Asthma Subjects | fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects |
| |
| Controlled Asthma Subjects | fenoTRACK for Controlled Adult and Pediatric Asthma Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenoTRACK Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 2 (Day 14) |
| Uncontrolled Cohort - Magnitude of change (Home Use) |
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Inclusion Criteria Uncontrolled Cohort:
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:
i. Cough ii. Wheezing iii. Shortness of breath iv. Chest tightness v. Nocturnal awakening with asthma vi. Limitation in activity due to asthma
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:
Exclusion Criteria Uncontrolled:
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
The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis
Subject is an employee/relative of the following:
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
Exclusion Criteria Controlled:
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:
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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vani Bhagwat, M.Sc. | Contact | 647-331-4256 | vbhagwat@precisionclinops.com | |
| Ming Lee, B.Sc. | Contact | 647-533-8001 | mlee@precisionclinops.com |
| Name | Affiliation | Role |
|---|---|---|
| Philip E. Silkoff, MD | Precision ClinOps LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bensch Clinical Research LLC | Recruiting | Stockton | California | 95207 | United States |
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Uncontrolled Cohort - Magnitude of change expressed both as absolute and percentage change, in actual at home using the fenoTRACK device in the uncontrolled cohort. |
| 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 | 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. | 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. | 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. | Visit 2 (Day 14) |
| AllerVie Clinical Research | Recruiting | Panama City | Florida | 32405 | United States |
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| AllerVie Clinical Research | Recruiting | Columbus | Georgia | 31904 | United States |
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| Paul A Shapero MD | Recruiting | Bangor | Maine | 04401 | United States |
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| AllerVie Clinical Research | Recruiting | Ellicott City | Maryland | 21043 | United States |
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| AllerVie Clinical Research | Recruiting | Glenn Dale | Maryland | 20769 | United States |
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| Nebraska Medical Research Institute, Inc. | Recruiting | Bellevue | Nebraska | 68123-4303 | United States |
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| Allergy Partners Clinical Research | Recruiting | Asheville | North Carolina | 28803 | United States |
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| Toledo Institute of Clinical Research Inc | Recruiting | Toledo | Ohio | 43617 | United States |
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| Orion Clinical Research | Recruiting | Austin | Texas | 78759 | United States |
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| Pharmaceutical Research & Consulting, Inc. | Recruiting | Dallas | Texas | 75231 | United States |
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| Western Sky Medical Research | Recruiting | El Paso | Texas | 79912 | United States |
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| Allergy, Asthma & Sinus Center, S.C. | Recruiting | Greenfield | Wisconsin | 53228 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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