Clinical trial NCT00562991: Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Official title: Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: exhaled NO
asthma
child
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Aerocrine AB
First posted: 2007-11-26
Enrollment: 99
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: asthmatic children

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: symptom-free days
timeFrame: 1 year time frame with visits every 3 months
Secondary outcomes:
measure: days spent in hospital,emergency room visits,physician or nurse contacts use of drugs, days on which school was missed, number of exacerbations
timeFrame: 1 year time frame
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St Jan
city: Brussels
country: Belgium
facility: Univ des enfants Reine Fabiola
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Hasselt
country: Belgium
facility: Virga Jesseziekenhuis
city: Turnhout
country: Belgium
facility: Algemeen ziekenhuis Turnhout, Campus Sint-Jozef
city: Verviers
country: Belgium
facility: CH Peltzer
Study officials:
affiliation: University Hospital, Antwerp
name: kristine N Desager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peirsman EJ, Carvelli TJ, Hage PY, Hanssens LS, Pattyn L, Raes MM, Sauer KA, Vermeulen F, Desager KN. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul;49(7):624-31. doi: 10.1002/ppul.22873. Epub 2013 Sep 4.