Study Stopped
Study terminated due to lack of care guidelines in the protocol.
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
Outcomes
1 other identifier
interventional
260
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Dec 2006
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJanuary 21, 2009
October 1, 2008
1.8 years
August 19, 2008
January 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma control days
12 months
Study Arms (2)
eNO group
ACTIVE COMPARATOReNO measurement is used to inform asthma management decisions
control group
NO INTERVENTIONAsthma is managed according to existing standard of care
Interventions
The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apieronlead
Study Sites (12)
Southern California Research
Mission Viejo, California, 92691, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
Allergy Associates of Hartford
Glastonbury, Connecticut, 06033, United States
Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, 60305, United States
The Asthma- Allergy Clinic& Research Center
Shreveport, Louisiana, 71105, United States
Chesapeake Clinical Research
Baltimore, Maryland, 21236, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Center for Allergy and Asthma
Highland Park, New Jersey, 08904, United States
Pulmonary & Allergy Associates P.A.
Summit, New Jersey, 07901, United States
Allergy, Asthma & Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Asthma & Allergy Research Associates
Upland, Pennsylvania, 19013, United States
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William E Berger, MD, MBA
Southern California Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 21, 2008
Study Start
December 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
January 21, 2009
Record last verified: 2008-10