Clinical trial NCT00739219: Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)
Official title: Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
inflammation
nitric oxide
eNO
FENO
Lead sponsor: Apieron
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 260
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Asthma control days
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Glastonbury
country: United States
facility: Allergy Associates of Hartford
state: Connecticut
city: River Forest
country: United States
facility: Asthma and Allergy Center of Chicago, S.C.
state: Illinois
city: Shreveport
country: United States
facility: The Asthma- Allergy Clinic& Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research
state: Maryland
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Highland Park
country: United States
facility: Center for Allergy and Asthma
state: New Jersey
city: Summit
country: United States
facility: Pulmonary & Allergy Associates P.A.
state: New Jersey
city: Lake Oswego
country: United States
facility: Allergy, Asthma & Dermatology Research Center, LLC
state: Oregon
city: Upland
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc.
state: Texas
Study officials:
affiliation: Southern California Research
name: William E Berger, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: