search
Back to results

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

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Apieron Insight eNO monitor
Sponsored by
Apieron
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, inflammation, nitric oxide, eNO, FENO

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southern California Research
  • Allergy & Asthma Associates of Santa Clara Valley Research Center
  • Allergy Associates of Hartford
  • Asthma and Allergy Center of Chicago, S.C.
  • The Asthma- Allergy Clinic& Research Center
  • Chesapeake Clinical Research
  • The Clinical Research Center, LLC
  • Center for Allergy and Asthma
  • Pulmonary & Allergy Associates P.A.
  • Allergy, Asthma & Dermatology Research Center, LLC
  • Asthma & Allergy Research Associates
  • Pharmaceutical Research & Consulting, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

eNO group

control group

Arm Description

eNO measurement is used to inform asthma management decisions

Asthma is managed according to existing standard of care

Outcomes

Primary Outcome Measures

Asthma control days

Secondary Outcome Measures

Full Information

First Posted
August 19, 2008
Last Updated
January 19, 2009
Sponsor
Apieron
search

1. Study Identification

Unique Protocol Identification Number
NCT00739219
Brief Title
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
Acronym
Outcomes
Official Title
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of care guidelines in the protocol.
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Apieron

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, inflammation, nitric oxide, eNO, FENO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eNO group
Arm Type
Active Comparator
Arm Description
eNO measurement is used to inform asthma management decisions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Asthma is managed according to existing standard of care
Intervention Type
Device
Intervention Name(s)
Apieron Insight eNO monitor
Intervention Description
The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.
Primary Outcome Measure Information:
Title
Asthma control days
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Berger, MD, MBA
Organizational Affiliation
Southern California Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Allergy & Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Allergy Associates of Hartford
City
Glastonbury
State/Province
Connecticut
ZIP/Postal Code
06033
Country
United States
Facility Name
Asthma and Allergy Center of Chicago, S.C.
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
The Asthma- Allergy Clinic& Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Chesapeake Clinical Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
The Clinical Research Center, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Center for Allergy and Asthma
City
Highland Park
State/Province
New Jersey
ZIP/Postal Code
08904
Country
United States
Facility Name
Pulmonary & Allergy Associates P.A.
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Allergy, Asthma & Dermatology Research Center, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Asthma & Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Pharmaceutical Research & Consulting, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs