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

This study has been terminated.
(Study terminated due to lack of care guidelines in the protocol.)
Sponsor:
Information provided by:
Apieron
ClinicalTrials.gov Identifier:
NCT00739219
First received: August 19, 2008
Last updated: January 19, 2009
Last verified: October 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer

Resource links provided by NLM:


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
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Apieron
Investigators
Principal Investigator: William E Berger, MD, MBA Southern California Research
  More Information

No publications provided

Responsible Party: Nina Peled, VP of Regulatory and Clinical Affairs, Apieron
ClinicalTrials.gov Identifier: NCT00739219     History of Changes
Other Study ID Numbers: CP00006
Study First Received: August 19, 2008
Last Updated: January 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Apieron:
Asthma
inflammation
nitric oxide
eNO
FENO

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

ClinicalTrials.gov processed this record on November 25, 2014