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TerminatedNCT00739219OutcomesUpdated Jan 21, 2009

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

A Phase 4 interventional study of Apieron Insight eNO monitor in Asthma, sponsored by Apieron. Terminated at 12 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by Apieron · Phase 4, Interventional, and Treatment

Why this study was terminated
Study terminated due to lack of care guidelines in the protocol.
Phase
Phase 4
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
12 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Asthma

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Keywords

  • Asthma
  • inflammation
  • nitric oxide
  • eNO
  • FENO
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 260 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Apieron is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (actual)

Study arms

  • Active comparator
    eNO group

    eNO measurement is used to inform asthma management decisions

    Device: Apieron Insight eNO monitor

  • No intervention
    control group

    Asthma is managed according to existing standard of care

Interventions

  • DeviceApieron 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.

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What researchers measure

Primary outcomes

  1. Asthma control days

    Time frame: 12 months

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00739219
Lead sponsor
Apieron
First posted
Aug 21, 2008
Start date
Dec 2006
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Jan 21, 2009

Study contacts

William E Berger, MD, MBA
principal investigator · Southern California Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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