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

Apieron

Status and phase: Terminated; Phase 4

Conditions: Asthma

Treatments: Device: Apieron Insight eNO monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739219

CP00006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

eNO group

Active Comparator group

Description:

eNO measurement is used to inform asthma management decisions

Treatment:

Device: Apieron Insight eNO monitor

control group

No Intervention group

Description:

Asthma is managed according to existing standard of care