NCT00562991

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 28, 2021

Status Verified

November 1, 2007

Enrollment Period

1 year

First QC Date

November 21, 2007

Last Update Submit

January 25, 2021

Conditions

Asthma

Keywords

exhaled NOasthmachild

Outcome Measures

Primary Outcomes (1)

  • symptom-free days

    1 year time frame with visits every 3 months

Secondary Outcomes (1)

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

    1 year time frame

Study Arms (2)

FeNO group

asthma patients, exhaled NO is used to monitor asthma

Device: measurement of exhaled NO is used to guide treatment

Symptom group

asthma patients, exhaled NO is not used to monitor asthma

Interventions

measurement of exhaled NO is used to guide treatmentDEVICE

exhaled NO

FeNO group

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

asthmatic children

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

Algemeen Ziekenhuis St Jan

Bruges, 8000, Belgium

Location

Univ des enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Virga Jesseziekenhuis

Hasselt, 3500, Belgium

Location

Algemeen ziekenhuis Turnhout, Campus Sint-Jozef

Turnhout, Belgium

Location

CH Peltzer

Verviers, 4800, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24039119DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • kristine N Desager, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

December 1, 2009

Last Updated

January 28, 2021

Record last verified: 2007-11

Locations

BE(7)