Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
- Conditions
- Asthma
- Registration Number
- NCT00739219
- Lead Sponsor
- Apieron
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 260
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Asthma control days 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
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 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
Scroll for more (2 remaining)Southern California Research🇺🇸Mission Viejo, California, United States