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:
Apieron
Information provided by:
Apieron
ClinicalTrials.gov Identifier:
NCT00739219
First received: August 19, 2008
Last updated: January 19, 2009
Last verified: October 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013