Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) (Outcomes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739219
Recruitment Status : Terminated (Study terminated due to lack of care guidelines in the protocol.)
First Posted : August 21, 2008
Last Update Posted : January 21, 2009
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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.

Condition or disease Intervention/treatment Phase
Asthma Device: Apieron Insight eNO monitor Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
Study Start Date : December 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: eNO group
eNO measurement is used to inform asthma management decisions
Device: Apieron 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.
No Intervention: control group
Asthma is managed according to existing standard of care

Primary Outcome Measures :
  1. Asthma control days [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739219

United States, California
Southern California Research
Mission Viejo, California, United States, 92691
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
United States, Connecticut
Allergy Associates of Hartford
Glastonbury, Connecticut, United States, 06033
United States, Illinois
Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, United States, 60305
United States, Louisiana
The Asthma- Allergy Clinic& Research Center
Shreveport, Louisiana, United States, 71105
United States, Maryland
Chesapeake Clinical Research
Baltimore, Maryland, United States, 21236
United States, Missouri
The Clinical Research Center, LLC
St. Louis, Missouri, United States, 63141
United States, New Jersey
Center for Allergy and Asthma
Highland Park, New Jersey, United States, 08904
Pulmonary & Allergy Associates P.A.
Summit, New Jersey, United States, 07901
United States, Oregon
Allergy, Asthma & Dermatology Research Center, LLC
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Asthma & Allergy Research Associates
Upland, Pennsylvania, United States, 19013
United States, Texas
Pharmaceutical Research & Consulting, Inc.
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Principal Investigator: William E Berger, MD, MBA Southern California Research

Responsible Party: Nina Peled, VP of Regulatory and Clinical Affairs, Apieron Identifier: NCT00739219     History of Changes
Other Study ID Numbers: CP00006
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: October 2008

Keywords provided by Apieron:
nitric oxide

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents