Asthma
Conditions
Keywords
Asthma, inflammation, nitric oxide, eNO, FENO
Brief summary
This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.
Detailed description
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.
Interventions
DEVICEApieron Insight eNO monitor
The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
Sponsors
Apieron
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre-existing diagnosis of asthma * Persistent, moderate or severe asthma as classified by NAEPP * Sub-optimally controlled asthma * Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids
Exclusion criteria
* Active cigarette smoking or ≥ 10 pack-years smoking history * Xolair taken in the past 6 months prior to enrollment * Oral prednisone taken in the last 4 weeks prior to enrollment * Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis * Subject is currently enrolled in another investigational drug study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma control days | 12 months |
Countries
United States
Outcome results
None listed