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

Phase 4

Terminated

• Conditions: Asthma
• Interventions: Device: Apieron Insight eNO monitor

• Registration Number: NCT00739219
• Lead Sponsor: Apieron

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Status Verified: 2008-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Last Update Submitted: 2009-01-19
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eNO group	Apieron Insight eNO monitor	eNO measurement is used to inform asthma management decisions

Primary Outcome Measures

Name	Time	Method
Asthma control days	12 months

Trial Locations

Locations (12)

Pulmonary & Allergy Associates P.A.; 🇺🇸 Summit, New Jersey, United States

Allergy & Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States

Asthma and Allergy Center of Chicago, S.C.; 🇺🇸 River Forest, Illinois, United States

The Asthma- Allergy Clinic& Research Center; 🇺🇸 Shreveport, Louisiana, United States

Southern California Research; 🇺🇸 Mission Viejo, California, United States

Chesapeake Clinical Research; 🇺🇸 Baltimore, Maryland, United States

The Clinical Research Center, LLC; 🇺🇸 St. Louis, Missouri, United States

Center for Allergy and Asthma; 🇺🇸 Highland Park, New Jersey, United States

Allergy, Asthma & Dermatology Research Center, LLC; 🇺🇸 Lake Oswego, Oregon, United States

Asthma & Allergy Research Associates; 🇺🇸 Upland, Pennsylvania, United States

Pharmaceutical Research & Consulting, Inc.; 🇺🇸 Dallas, Texas, United States

Allergy Associates of Hartford; 🇺🇸 Glastonbury, Connecticut, United States