Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) - Full Text View

Purpose

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	Intervention	Phase
Asthma	Device: Apieron Insight eNO monitor	Phase IV

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer

Further study details as provided by Apieron:

Primary Outcome Measures:

Asthma control days [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	260
Study Start Date:	December 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
eNO group: Active Comparator 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.
control group: No Intervention Asthma is managed according to existing standard of care

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739219

Locations


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
	Pulmonary & Allergy Associates P.A.
	Summit, New Jersey, United States, 07901
	Center for Allergy and Asthma
	Highland Park, New Jersey, United States, 08904

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

Apieron

Investigators


Principal Investigator:	William E Berger, MD, MBA	Southern California Research

More Information

Responsible Party:	Apieron ( Nina Peled, VP of Regulatory and Clinical Affairs )
Study ID Numbers:	CP00006
First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739219
Health Authority:	United States: Institutional Review Board

Keywords provided by Apieron:

Asthma

inflammation

nitric oxide

eNO

FENO

Study placed in the following topic categories:

Nitric Oxide

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Inflammation

Additional relevant MeSH terms:

Respiratory System Agents

Vasodilator Agents

Neurotransmitter Agents

Antioxidants

Bronchial Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Cardiovascular Agents

Protective Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Free Radical Scavengers

Endothelium-Dependent Relaxing Factors

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Apieron
Information provided by:	Apieron
ClinicalTrials.gov Identifier:	NCT00739219