Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment (eNOugh)

November 3, 2011 updated by: Aerocrine AB

A Multicenter, Device Randomized, Open-label Prospective Single-cohort Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment

The purpose of this study is to demonstrate substantial equivalence between two medical devices which measure nitric oxide in exhaled breath, NIOX MINO® and NIOX® in Symptomatic Asthmatic Adults and Children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asthma is a chronic inflammatory disorder of the airways. Chronically inflamed airways are hyperresponsive; they become obstructed and airflow is limited (by bronchoconstriction, mucus plugs, and increased inflammation) when airways are exposed to various risk factors. Asthma causes recurring episodes of wheezing, breathlessness, chest tightness, and coughing particularly at night or in the early morning.

NO is an important endogenous regulatory molecule that is widely distributed throughout the body. The detection of NO in exhaled air was first reported in 1991, and, soon after it was shown that the levels NO in exhaled air are elevated in patients with asthma. There is now much evidence showing that measurement of the concentration of NO in exhaled air offers a useful non-invasive method of assessing inflammatory airway disease.

Exhaled NO is not increased during bronchospasm unless there is coexisting inflammation. Exhaled NO may have a valuable role in differentiating between the inflammatory and bronchospastic components of clinical asthma, and is also useful for guiding the therapeutic use of steroids and other anti-inflammatory agents.

A study on asthmatics and non-asthmatics subjects has shown that substantial equivalence exists between the stationary device NIOX® and the hand held device NIOX MINO® when comparing NO measurements, when similar conditions are considered and examinations are made as consistently as possible.

In a study with the stationary device NIOX®, exhaled NO was measured before and after two weeks of inhaled corticosteroid treatment in unstable steroid-naïve adult and paediatric asthmatic subjects. The result was a 50.5% mean reduction of exhaled NO. The change in exhaled NO was also compared to change in standard asthma outcome measures, asthma symptoms and spirometry.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

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

  • Sweden
      • Höllviken, Sweden, SE-23651
        • Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken
  • United Kingdom
      • Aberdeen, United Kingdom, AB252AY
        • Department of General Practice & Primary Care University of Aberdeen

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

2 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children, and adults.
  • A history of physician-diagnosed asthma or asthma diagnosed by a physician.
  • Spirometry performed parameters.
  • An increased FENO value.
  • Symptomatic asthma as defined on the Asthma Control Questionnaire® (ACQ).

Exclusion Criteria:

  • Use of oral corticosteroids.
  • Use of intranasal corticosteroids.
  • Use of non-steroidal anti-asthma drugs.
  • Current serious conditions and/or therapies that are confounding factors.
  • Pregnancy.
  • Other significant respiratory diseases and/or cardiovascular diseases.
  • Current participation in another interventional clinical study.
  • Inability to comply with the study procedures, e.g. spirometry and FENO measurements according to standard procedures.
  • Unwillingness to sign informed consent and comply with treatment and visits.
  • Smoking within 6 months before the study, or a smoking history of >10 pack years or an equivalent amount of other tobacco use.
  • Known alcohol or drug abuser.
  • Food and beverage (other than water) intake within 1 hour before first FENO measurement
  • Nicotine (including nicotine chewing gum, nicotine patch, snuff etc) use within 1 hour before first FENO measurement.
  • Strenuous exercise within 1 hour before first FENO measurement

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary analysis variable will be the percent change in FENO measured with
NIOX MINO® and NIOX® between Visit 1 to Visit 2.

Secondary Outcome Measures

Outcome Measure
Agreement between NIOX MINO® and NIOX® will be assessed by comparing
individual pair-wise FENO measurements from visit V1.
The change in FENO measured with NIOX MINO following corticosteroid therapy
in asthma will be compared with improvements in standard asthma outcome
measures (asthma symptoms and spirometry).
To investigate the inter-operator variability FENO measurements with
NIOX MINO in the same subject when different operators take FENO measurements. Three operator each takes two completed measurements in the same subject in a point of care setting.

Collaborators and Investigators

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

Sponsor

Aerocrine AB

Investigators

  • Study Chair: David Price, Professor, Dept of General Practice and Primary Care, University of Aberdeen
  • Study Chair: Sven-Erik Dahlén, Professor, Unit for Experimental Asthma and Allergy Research Division of Physiology, The National Institute of Environmental Medicine Karolinska Institutet

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

October 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 3, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AER-036

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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