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

January 19, 2009 updated by: Apieron

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma control days
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apieron

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 19, 2009

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe