Evaluate the effect of topical steroids on salivary cortisol levels, and assess the correlation between salivary cortisol levels, symptoms of asthma, and lungfunction in children with asthma and/or rhinitis
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
difference in salivary cortisol level before and during or after treatment with
topical steroids
Secondary outcome
correlation of salivary cortisol, symptoms of asthma, and lungfunction
Background summary
Collection of saliva is a well established noninvasive way to assess cortisol
levels in children. We have recently demonstrated that salivary cortisol levels
are significantly lower in children using inhaled and/or intranasal steroids
compared to a control group. It is unknown if the reduced salivary cortisol
levels are due to the chronic inflammatory disease or to the use of topical
steroids.
To the best of our knowledge, salivary cortisol levels have not been determined
in individual children before, during and after treatment with topical
steroids. Furthermore, it is not known if there is any correlation between
cortisol levels and symptoms or lungfunction.
In the present study we want to evaluate intraindividual salivary cortisol
levels before, during and after treatment with topical steroids. This way we
are able to determine whether topical steroids induce an additional suppression
of salivary cortisol levels, and if these levels increase after discontinuation
of the steroids. We also aim to study the correlation between salivary cortisol
levels, symptoms of asthma, and lungfunction.
Study objective
Evaluate the effect of topical steroids on salivary cortisol levels, and assess
the correlation between salivary cortisol levels, symptoms of asthma, and
lungfunction in children with asthma and/or rhinitis
Study design
All eligible children who visit our ambulatory pediatric asthma clinic in the
period september 2010- september 2011, will be asked to partcipate. Standard
diagnostic procedures will be performed (lungfunction and allergy test). The
following data will be recorded: height, weight, body mass index, Tanner state,
type of inhalation device, allergies. For newly diagnosed patients, duration of
symptoms and dose of prescribed topical steroids. For patients in whom the
topical steriods are discontinued, the dose of topical steroids used in the
last 3 months are recorded.
In addition, the asthma symptom score will be recorded on the day the saliva is
collected by using the validated asthma control test for children.
Study burden and risks
Collection of saliva by chewing on a cottonwool swab is considered
childfriendly and with minimal burden. We expect no risk for the participants
Henri Dunantweg 2
8934 AD
NL
Henri Dunantweg 2
8934 AD
NL
Listed location countries
Age
Inclusion criteria
children 6-18 years
newly referred children who are diagnosed with asthma and/or rhinitis and who are not already using topical steroids
children with stable asthma and/or rhinitis in whom topical steroids can be tapered down to zero according to international guidelines
Exclusion criteria
informed consent is not obtained
if a child is unwilling to participate during the study
a chronic medical condition other than asthma and/or rhinitis
use of oral steroids in the past 3 months
use of concurrent medication which may potentially affect steroidmetabolism
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 | NL33148.099.10 |