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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

August 19, 2008
January 19, 2009
December 2006
October 2008   (final data collection date for primary outcome measure)
Asthma control days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739219 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
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.
  • Active Comparator: eNO group
    eNO measurement is used to inform asthma management decisions
    Intervention: Device: Apieron Insight eNO monitor
  • No Intervention: control group
    Asthma is managed according to existing standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
260
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00739219
CP00006
No
Nina Peled, VP of Regulatory and Clinical Affairs, Apieron
Apieron
Not Provided
Principal Investigator: William E Berger, MD, MBA Southern California Research
Apieron
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP