Exhaled Nitric Oxide in Asthma Management

May 14, 2014 updated by: David Price, Prof., MD, Research in Real-Life Ltd

Exhaled Nitric Oxide in Asthma Management: a Retrospective Real-life Observational Evaluation of the Use of Exhaled Nitric Oxide Measurements for Asthma Management in a UK Primary Care Population

This study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO) as a marker of underlying airway inflammation to guide appropriate management. As exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eNO monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB24 3BA
        • Research in Real Life

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthma patients who either:

  • Use eNO monitoring in their asthma management
  • Do not use eNO monitoring

Description

Inclusion Criteria:

  1. Aged: 6-80 years
  2. Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records)
  3. Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year)
  4. Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD)

Exclusion Criteria:

  1. Had a COPD read code at any time; and/or
  2. Had any chronic respiratory disease, except asthma, at any time; and/or
  3. Patients on maintenance oral steroids during baseline year
  4. Smoker or ex-smoker aged over 60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
eNO monitoring
Patients undergoing eNO monitoring at the index prescription date
Device: eNO monitoring
Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®
No eNO monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe Exacerbation Rate
Time Frame: One Year Outcome Period

Where exacerbations are defined as an occurrence of:

Unscheduled hospital admissions / Emergency Room attendance for asthma, OR Use of acute courses of oral steroids
One Year Outcome Period
Proxy Asthma Control
Time Frame: One year outcome period
  1. No recorded hospital attendance for asthma, including admission, Emergency Room (ER) attendance or Out-Patient Department (OPD) attendance, AND
  2. No prescriptions for acute courses of oral steroids, AND
  3. No GP consultations, hospital admissions or ER attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
One year outcome period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control (including SABA)
Time Frame: One year outcome
Proxy asthma control (defined above), including the absence of average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline
One year outcome
Respiratory-related hospitalisations and referrals
Time Frame: One year outcome period
Mean number of respiratory-related hospitalisations and referrals per patient during the outcome year
One year outcome period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research in Real-Life Ltd

Collaborators

Aerocrine AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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