does the use of fluticasone as an inhaled corticosteroid influence the determination of saliva cortisol?
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference of levels of saliva cortisol before and after the inhalation of 250
microgram fluticasone
Secondary outcome
geen
Background summary
The use of corticosteroids can influence the hypophyseal-adrenal-axis. Saliva
cortisol can be used to investigate the functioning of this axis. There is a
strong correlation between the level of free saliva cortisol and the serum
cortisol level. The use of saliva to determine the cortisol level is more
convenient for the patient in comparison with the use of serum levels.
For the reliability of the use of saliva it is essential that cortisol levels
are independent of factors other than patient-bound. In the manual of the
manufacturer it is stated that the use of beclomethasone and budesonide do not
influence the cortisol determination. However, it is unknown whether the use of
fluticasone influences this determination. Information hereabout is necessary,
because many patients use fluticasone as an inhaled corticosteroid.
Study objective
does the use of fluticasone as an inhaled corticosteroid influence the
determination of saliva cortisol?
Study design
In 30 adult males saliva is harvested with the use of the Salivette(r), an
especially for saliva collection design device, before and after the inhalation
of fluticasone 250 microgram.
Study burden and risks
The burden for the volunteers includes a visit to the hospital, chewing twice
on a Salivette(r), and the inhalation of fluticasone. Fluticasone is widely
used by many patients and side effects only occur after ongoing use.
Postbus 888
8901 BR Leeuwarden
Nederland
Postbus 888
8901 BR Leeuwarden
Nederland
Listed location countries
Age
Inclusion criteria
male, age 18 - 30 years of age
Exclusion criteria
use of medications and/or drugs in the week prior to the study; contra-indications for administration of inhaled corticosteroids; allergic to fluticasone
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 | NL30565.099.09 |