NCT01839851

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 11, 2014

Status Verified

October 1, 2013

Enrollment Period

1.6 years

First QC Date

April 22, 2013

Last Update Submit

March 9, 2014

Conditions

ASTHMAALLERGIC RHINITIS

Keywords

Hair cortisolasthmaallergic rhinitisinhaled corticosteroidsintranasal glucocorticoids

Outcome Measures

Primary Outcomes (1)

  • Change in concentration of hair cortisol under topical corticosteroid treatment

    The primary outcome will be evaluated separately in each of the three distinct study cohorts

    Hair cortisol concentration 3 months after initiation of treatment with inhaled or intranasal corticosteroids compared to concentration of hair cortisol at study initiation

Study Arms (3)

Asthma

Treatment with any inhaled corticosteroid

Drug: Treatment with any inhaled corticosteroid

Allergic rhinitis

Treatment with any intranasal glucocorticoid

Drug: Treatment with any intranasal glucocorticoid

Asthma and allergic rhinitis

Inhaled corticosteroid + intranasal glucocorticoid

Drug: Treatment with any inhaled corticosteroidDrug: Treatment with any intranasal glucocorticoid

Interventions

Treatment with any inhaled corticosteroidDRUG

Use of any inhaled corticosteroid (daily frequency and dose will be registered)

Also known as: Symbicort, Budicort, Qvar
AsthmaAsthma and allergic rhinitis
Treatment with any intranasal glucocorticoidDRUG

Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)

Also known as: Steronase
Allergic rhinitisAsthma and allergic rhinitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Related Publications (1)

  • Stalder T, Kirschbaum C. Analysis of cortisol in hair--state of the art and future directions. Brain Behav Immun. 2012 Oct;26(7):1019-29. doi: 10.1016/j.bbi.2012.02.002. Epub 2012 Feb 15.

    PMID: 22366690BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Interventions

TherapeuticsBudesonide, Formoterol Fumarate Drug CombinationBeclomethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsPregnadienetriolsPregnadienesSteroids, Chlorinated

Study Officials

  • Eilon Krashin, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eilon Krashin, MD

CONTACT

972-50-4233063eilon.krashin@clalit.org.il

Leader Avi, MD

CONTACT

avi.leader@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 25, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 11, 2014

Record last verified: 2013-10

Locations

IL(1)