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ASTHMANCT01839851

Hair Cortisol in Asthma or Allergic Rhinitis Treated With Topical Corticosteroids

An observational study of ASTHMA and ALLERGIC RHINITIS, run by Meir Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ASTHMA, ALLERGIC RHINITIS
What is being tested?
Treatment with any inhaled corticosteroid and Treatment with any intranasal glucocorticoid
How many people
60 participants
Where
1 siteIsrael
Study dates
May 2013to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Leader Avi, MD contact

avi.leader@clalit.org.il

Israel1 site, 1 recruiting
  • Meir Medical Center

    Kfar Saba

    Krashin Eilon, MD

    Recruiting

Other trials in Israel

About this study

Official title: Evaluation of Hair Cortisol in Patients With Asthma or Allergic Rhinitis Treated With Topical (Inhaled or Intranasal) 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.

Read the 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.

Being tested
Treatment with any inhaled corticosteroid, Treatment with any intranasal glucocorticoid
Keywords
Hair cortisol, asthma, allergic rhinitis, inhaled corticosteroids, intranasal glucocorticoids
Medical subject headings
Asthma, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment with any inhaled corticosteroidDrug

    Also called Symbicort, Budicort, Qvar

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

  • Treatment with any intranasal glucocorticoidDrug

    Also called Steronase

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

Study groups in NCT01839851
Study groupRoleWhat they receive
AsthmaTreatment with any inhaled corticosteroid
Receives: Drug: Treatment with any inhaled corticosteroid
Allergic rhinitisTreatment with any intranasal glucocorticoid
Receives: Drug: Treatment with any intranasal glucocorticoid
Asthma and allergic rhinitisInhaled corticosteroid + intranasal glucocorticoid
Receives: Drug: Treatment with any inhaled corticosteroid; Drug: Treatment with any intranasal glucocorticoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839851
Sponsor's protocol ID
MMC-13-0047-CTIL
Status last verified
Oct 2013
First submitted
22 Apr 2013
Last updated
11 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22366690

Questions about this trial

What is this clinical trial studying?

An observational study of ASTHMA and ALLERGIC RHINITIS, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eilon Krashin, MD (972-50-4233063, eilon.krashin@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2014.

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