To determine exercised-induced bronchoconstriction with an objective and standardized exercise test for infants and young children (3-6 years); to compare resistance and compliance in wheezy children and healthy children before and after exercise-…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Number of children with exercise-induced bronchoconstriction in the wheeze
group compared to the healthy group.
-Number of children with bronchoconstriction measured by FOT at 3-6 years of
age compared to number of children with bronchoconstriction measured with
treadmill/ histamine challenge at 7-8 years of age.
-Number of children able to perform the test at 3-6 years
-Reproducibility
Secondary outcome
not applicable
Background summary
Wheezy disorders are common and form a heterogeneous group. The majority of
infants with wheeze do not have an increased risk of asthma later in life.
Hence it would be important to distinguish between early transient, late-onset
and persistent wheeze. The latter is associated with asthma and patients need
treatment. Because these wheezy disorders are difficult to distinguish from
each other clinically, it would be helpful to have some objective measures for
diagnosis. Asthma has characteristic features such as reversible airway
obstruction, bronchial hyperresponsiveness and airway inflammation. In older
children and adults, bronchial hyperresponsiveness can be measured using
pharmacological agents such as histamine or using exercise tests. Due to age
dependent limitation of cooperation, lung function measurements and challenge
tests in preschool aged children are difficult to perform. Forced Oscillation
Technique (FOT) measures resistance and reactance and has the potential to
determine the presence of airway obstruction or hyper-reactivity.
Study objective
To determine exercised-induced bronchoconstriction with an objective and
standardized exercise test for infants and young children (3-6 years); to
compare resistance and compliance in wheezy children and healthy children
before and after exercise-testing; to study whether young children with
exercised-induced bronchoconstriction remain hyperreactive when they grow
older.
Study design
prospective, observational study
Used methods:
-exercise test (free running)
-lung function test (forced oscillation technique)
-Exercise test (tread mill)
-Histamine challenge
Intervention
Exercise testing/ Histamine Challenge test
Study burden and risks
Children perform the test, which consists of 6 minutes free running, once. Lung
function measurements are performed using forced oscillation technique before
and after the running. Free running is a normal activity for children and risks
are therefore low. Heart rate will be monitored during the test. In case of
bronchoconstrition and no return to the baseline level, a short acting beta2
agonist will be given to reverse the bronchoconstriction. A document that has
been developed by the ad hoc group for the development of implementing
guidelines for Directive 2001/20/EC1 relating to good clinical practice in the
conduct of clinical trials on medicinal products for human use, chaired by the
European Commission considered spirometry to have no risk and exercise testing
as minor increase above minimal risk.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Age: 3-6 years
-Asthma:
Children with episodic attacks (>3 times/year) of wheeze, shortness of breath or cough.
-Controls:
Healthy, no respiratory smptoms
Exclusion criteria
-recent respiratory infection,
-severe respiratory symptoms with need for oral steroids,
-history of prematurity and/or intensive care treatment,
-other respiratory disorders such as Cystic Fibrosis,
-other disorders that limit the possibily to perform an exercise test
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20182.000.08 |