NCT07228026招募中不适用
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 Inc13 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年9月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 13
- 主要终点
- Uncontrolled Cohort - Magnitude of change in FeNO Values
研究概览
简要总结
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
详细描述
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
排除标准
- •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:
- •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.
- •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
- •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:
- •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
研究组 & 干预措施
Uncontrolled Asthma Subjects
fenoTRACK for Uncontrolled Adult and Pediatric Asthma Subjects
干预措施: fenoTRACK Device (Device)
Controlled Asthma Subjects
fenoTRACK for Controlled Adult and Pediatric Asthma Subjects
干预措施: fenoTRACK Device (Device)
结局指标
主要结局
Uncontrolled Cohort - Magnitude of change in FeNO Values
时间窗: 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.
次要结局
- Uncontrolled Cohort - Magnitude of change (POC)(Visit 2 (Day 14))
- Uncontrolled Cohort - Magnitude of change (Home Use)(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(Visit 2 (Day 14))
- Uncontrolled Cohort - Change in best spirometry measures(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(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(Visit 2 (Day 14))
研究者
研究点 (13)
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