Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids
Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids
The purpose of this study is to prospectively examine the relation between topical
 corticosteroid use and hair cortisol concentration, among patients with moderate persistent
 asthma or allergic rhinitis. The investigators hypothesize that patients with asthma or
 allergic rhinitis treated with topical corticosteroids (i.e. inhaled corticosteroids (ICS) or
 intranasal glucocorticoids (INGC)) have higher levels of hair cortisol after 3 months of
 treatment than during the 3 months prior to initiation of treatment.
Inhaled corticosteroids have proven effective in the treatment of asthma, suppressing airway
 inflammation and reducing bronchial hyper-responsiveness. Beneficial clinical outcomes
 include fewer asthmatic symptoms, increased lung function, improved asthma-specific quality
 of life, and fewer asthmatic exacerbations, including severe attacks resulting in
 hospitalization or death. ICS are commonly used when asthmatic episodes are too frequent or
 too severe to be controlled solely by short acting beta agonists. ICS have few adverse
 effects at low to medium doses, which are mainly local effects such as hoarseness and oral
 thrush. On the other hand, high doses of ICS are associated with systemic effects such as
 increased risk of skin bruising, cataracts, elevated intraocular pressure and accelerated
 loss of bone mass. While there is less evidence pointing towards systemic effects of low to
 medium doses of ICS, several studies have suggested that such an effect exists. One study
 demonstrated changes in the hypothalamic-pituitary-adrenal (HPA) axis with ICS administration
 at doses as low as 88 μg of fluticasone per day. Moreover, a study in children showed ICS did
 not influence basal cortisol levels but significantly reduced peak cortisol and
 adrenocorticotropic hormone levels.

 Hence, the extent of the systemic effect of ICS at high doses and especially at low to medium
 doses is not fully understood. This is partly due to the nature of most of the systemic
 side-effects which necessitate long term follow-up of a large population of patients, but
 also because of technical difficulties in assessing systemic cortisol levels over a prolonged
 period of time.

 A similar clinical conundrum exists with intranasal glucocorticoids (INGC), regarding their
 systemic effect. INGCs are considered the first-line of medical therapy for allergic rhinitis
 and are more effective than systemic antihistamines. The most common adverse effects stem
 from local irritation of the nasal mucosa, while systemic effects are much rarer. The effect
 of INGC on the HPA axis and growth has been evaluated extensively in children. Most studies,
 especially those with the second generation agents and recommended doses, showed no or
 limited HPA suppression. Despite these reassuring data, the adverse effects of INGC can be
 additive with those of other glucocorticoid preparations for comorbid conditions, and thus
 caution should be exercised. A handful of studies have demonstrated detrimental effects of
 INGC therapy on bone mineral density and intraocular pressure. These studies have small
 sample sizes and have not clearly proven whether these effects result in clinically relevant
 long term outcomes, such as fractures. As a result, these studies are not reflected in
 current practice guidelines.

 Cortisol levels are routinely determined from blood, salivary or urinary samples However,
 these methods do not provide information on long term cortisol secretion, accounting for the
 variability of HPA axis activity. There is a growing pool of evidence that shows that Hair
 Cortisol Concentration (HCC) examination provides a reliable retrospective estimation of
 integrated cortisol secretion over a period of several months. Hair grows at a rate of about
 1 cm/month, thus 3 cm of hair would give an indication of the cortisol levels over the
 previous 3 months. HCC correlates with 24h urinary cortisol levels, but not with salivary or
 serum cortisol, supporting use of HCC as an indicator of cortisol levels over time rather
 than a point measurement. HCC has been evaluated in several clinical settings in which
 activity of the HPA axis and cortisol levels over a period of time are of interest. Studies
 have demonstrated increased levels of hair cortisol in patients with stress as well as in
 conditions associated with stress such as pregnancy, unemployment, PTSD, alcohol withdrawal,
 chronic pain and myocardial infarction. Elevated levels of hair cortisol were also shown in
 Cushing's syndrome, with reduced levels after correction of the disorder.

 No study to date has examined the correlation between the use of inhaled or intranasal
 corticosteroids and levels of cortisol in hair. If such a correlation exists, it would
 indicate systemic absorption of these topical steroids which in turn would suggest a
 potential for systemic side effects. In addition, and pending further studies, HCC may serve
 as a validated test to determine which patients are more prone to systemic side effects, as
 well as help in assessing compliance.
Inclusion Criteria:

 -  Age of 18 years or older

 -  Diagnosis of asthma or allergic rhinitis, or both.

 -  Planned initiation of treatment with ICS and/or INGC at study recruitment, according
 to routine clinical practice

 Exclusion Criteria:

 -  Use of inhaled, systemic or topical corticosteroids at study initiation, or during the
 previous 6 months.

 -  Use of topical corticosteroid ointments or cream, or systemic corticosteroids during
 the study period.

 -  Disorders associated with disruption of HPA axis (Cushing syndrome, Addison syndrome).

 -  Insufficient hair for analysis

 -  Bleaching or use of artificial hair color.

 -  Pregnancy