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Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01839851
First Posted: April 25, 2013
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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.

Condition Intervention
ASTHMA ALLERGIC RHINITIS Drug: Treatment with any inhaled corticosteroid Drug: Treatment with any intranasal glucocorticoid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Hair Cortisol in Patients With Asthma or Allergic Rhinitis Treated With Topical (Inhaled or Intranasal) Corticosteroids

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Change in concentration of hair cortisol under topical corticosteroid treatment [ Time Frame: Hair cortisol concentration 3 months after initiation of treatment with inhaled or intranasal corticosteroids compared to concentration of hair cortisol at study initiation ]
    The primary outcome will be evaluated separately in each of the three distinct study cohorts


Biospecimen Retention:   Samples Without DNA
Hair

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asthma
Treatment with any inhaled corticosteroid
Drug: Treatment with any inhaled corticosteroid
Use of any inhaled corticosteroid (daily frequency and dose will be registered)
Other Names:
  • Symbicort
  • Budicort
  • Qvar
Allergic rhinitis
Treatment with any intranasal glucocorticoid
Drug: Treatment with any intranasal glucocorticoid
Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)
Other Name: Steronase
Asthma and allergic rhinitis
Inhaled corticosteroid + intranasal glucocorticoid
Drug: Treatment with any inhaled corticosteroid
Use of any inhaled corticosteroid (daily frequency and dose will be registered)
Other Names:
  • Symbicort
  • Budicort
  • Qvar
Drug: Treatment with any intranasal glucocorticoid
Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)
Other Name: Steronase

  Hide Detailed Description

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with asthma or allergic rhinitis requiring treatment with topical corticosteroids (inhaled corticosteroids or intranasal glucocorticoids), presenting to the Meir Medical Center Allergy and Immunology clinic.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839851


Contacts
Contact: Eilon Krashin, MD 972-50-4233063 eilon.krashin@clalit.org.il
Contact: Leader Avi, MD avi.leader@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Principal Investigator: Krashin Eilon, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Eilon Krashin, MD Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01839851     History of Changes
Other Study ID Numbers: MMC-13-0047-CTIL
First Submitted: April 22, 2013
First Posted: April 25, 2013
Last Update Posted: March 11, 2014
Last Verified: October 2013

Keywords provided by Meir Medical Center:
Hair cortisol
asthma
allergic rhinitis
inhaled corticosteroids
intranasal glucocorticoids

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Glucocorticoids
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents