Monitoring Asthma Treatment Using Exhaled Nitric Oxide

Asthma is a chronic inflammatory condition in which the airways develop increased responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It is characterized by airway hyper-responsiveness, inflammation, increased mucus production, and airway obstruction. Since inflammation is an important feature of asthma, the use of non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose of the study is to relate costs associated with healthcare utilization and loss of work and school time to the primary health outcome of cumulative number of symptom-free days. This will enable the researchers to determine whether the costs of monitoring exhaled NO to regular management strategy in recently diagnosed asthma will be offset by reductions in other costs of asthma-related care, and, if not, whether the additional costs are likely to be acceptable in terms of the improvement in health outcomes as measured by the additional number of symptom-free days.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female children, aged 6-14 years
A documented history of asthma for a period of at least 6 months
Mild to severe persistent asthma according to GINA guidelines
A documented history of allergic sensitization (positive skin prick test or specific IgE
Subject's guardian/parent should be able to complete a symptom score on behalf of the subject.
Subject's guardian/parent should be able to send a symptom score weekly by sms
Both parents have to give written informed consent to participate in the study

Exclusion criteria

Received any investigational study medication in the 4 weeks prior to screening Visit
Significant comorbidity such as concurrent infection, history of prematurity, history of bronchopulmonary dysplasia, cystic fibrosis, other chronic lung diseases, and other severe chronic diseases
Acute asthma exacerbation within 4 weeks of screening visit
Hospitalization within 12 weeks of screening visit
Systemic corticosteroids within 12 weeks of screening visit
Oral corticosteroid dependence

Treatment and study plan

measurement of exhaled NO is used to guide treatment

Device

exhaled NO

Primary outcomes

symptom-free days

Time frame: 1 year time frame with visits every 3 months

Secondary outcomes

days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations

Time frame: 1 year time frame

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

Aerocrine AB
Merck Sharp & Dohme LLC

Registry information

Acronym: NOASTHMA

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Nov 26, 2007
Registry last updated: Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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