COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388570
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 4, 2011
Information provided by:
Aerocrine AB

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Device: The Aerocrine NIOX MINO® Airway Inflammation Monitor Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Device Randomized, Open-label Prospective Single-cohort Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment
Study Start Date : October 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Secondary Outcome Measures :
  1. Agreement between NIOX MINO® and NIOX® will be assessed by comparing
  2. individual pair-wise FENO measurements from visit V1.
  3. The change in FENO measured with NIOX MINO following corticosteroid therapy
  4. in asthma will be compared with improvements in standard asthma outcome
  5. measures (asthma symptoms and spirometry).
  6. To investigate the inter-operator variability FENO measurements with
  7. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388570

Layout table for location information
Näsets Läkargrupp, Falsterbov. 79, SE-23651 Höllviken
Höllviken, Sweden, SE-23651
United Kingdom
Department of General Practice & Primary Care University of Aberdeen
Aberdeen, United Kingdom, AB252AY
Sponsors and Collaborators
Aerocrine AB
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Aerocrine AB, Ulrika Stein Grive, Aerocrine AB Identifier: NCT00388570    
Other Study ID Numbers: AER-036
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: November 2011
Keywords provided by Aerocrine AB:
nitric oxide
airway inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases