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Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids

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.
ClinicalTrials.gov Identifier: NCT01839851
Recruitment Status : Unknown
Verified October 2013 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : April 25, 2013
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
ASTHMA ALLERGIC RHINITIS Drug: Treatment with any inhaled corticosteroid Drug: Treatment with any intranasal glucocorticoid

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : May 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 25, 2013    Key Record Dates
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