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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
Southern California Research
Mission Viejo, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Allergy Associates of Hartford
Glastonbury, Connecticut, United States
Asthma control days
Time frame: 12 months
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Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, United States
The Asthma- Allergy Clinic& Research Center
Shreveport, Louisiana, United States
Chesapeake Clinical Research
Baltimore, Maryland, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Center for Allergy and Asthma
Highland Park, New Jersey, United States
Pulmonary & Allergy Associates P.A.
Summit, New Jersey, United States
Allergy, Asthma & Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
...and 2 more locations