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Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01839851
First received: April 22, 2013
Last updated: March 9, 2014
Last verified: October 2013
  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 ] [ Designated as safety issue: Yes ]
    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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 22, 2013
Last Updated: March 9, 2014
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014