Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Vani Bhagwat, M.Sc.
CONTACT
Ming Lee, B.Sc.
CONTACT
Lead
Biometry Inc
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 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 2. 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
Age
5–100
Sex
ALL
Healthy volunteers
Not accepted
