Status:

TERMINATED

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

Lead Sponsor:

Apieron

Conditions:

Asthma

Eligibility:

All Genders

12+ years

Phase:

PHASE4

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). A...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT00739219

Start Date

December 1 2006

End Date

October 1 2008

Last Update

January 21 2009

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Southern California Research

Mission Viejo, California, United States, 92691

2

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States, 95117

3

Allergy Associates of Hartford

Glastonbury, Connecticut, United States, 06033

4

Asthma and Allergy Center of Chicago, S.C.

River Forest, Illinois, United States, 60305

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