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

Asthma Clinical Trial

— Outcomes  

Official title:

Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00739219
• Other study ID #: CP00006
• Status: Terminated
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: January 19, 2009
• Start date: December 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Apieron
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 260
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Chesapeake Clinical Research	Baltimore	Maryland
United States	Pharmaceutical Research & Consulting, Inc.	Dallas	Texas
United States	Allergy Associates of Hartford	Glastonbury	Connecticut
United States	Center for Allergy and Asthma	Highland Park	New Jersey
United States	Allergy, Asthma & Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Southern California Research	Mission Viejo	California
United States	Asthma and Allergy Center of Chicago, S.C.	River Forest	Illinois
United States	Allergy & Asthma Associates of Santa Clara Valley Research Center	San Jose	California
United States	The Asthma- Allergy Clinic& Research Center	Shreveport	Louisiana
United States	The Clinical Research Center, LLC	St. Louis	Missouri
United States	Pulmonary & Allergy Associates P.A.	Summit	New Jersey
United States	Asthma & Allergy Research Associates	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Apieron

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control days		12 months	No