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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exhaled Nitric Oxide in Asthma Management

NCT02140684

Asthma

SUSPENDED

Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System

NCT00739531

Asthma

COMPLETED

The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients

NCT00575445

Asthma

TERMINATED

Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents

NCT00114413

Asthma

COMPLETED NA

Exhaled Nitric Oxide and Nasal Lavage Fluid

NCT00773578

Asthma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eNO group

eNO measurement is used to inform asthma management decisions

Group Type ACTIVE_COMPARATOR

Apieron Insight eNO monitor

Intervention Type DEVICE

The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.

control group

Asthma is managed according to existing standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No