Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

This study is currently recruiting participants.

Verified by HaEmek Medical Center, Israel, November 2007

Sponsored by:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00560625

Purpose

Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is associated with suppression of endogenous cortisol production, as seen in patients treated with pharmacologic doses of oral or parenteral steroids.

Condition
Adrenal Insufficency

Drug Information available for: Fluticasone Fluticasone propionate Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-Pituitary-Adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

stimulated serum cortisol levels [ Time Frame: within 30 days of treatment ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008

Detailed Description:

The normalcy of the hypothalmic-pituitary-adrenal (HPA) axis of enrolled subjects will be assessed by low dose (1mcg) corticotropin (ACTH)stimulation test. Serum cortisol levels will be measured before , 30 minutes and 60 minutes after 1 mcg ACTH intravenous injection.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

hospital-based respiratory diseases clinic

Criteria

Inclusion Criteria:

patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks

Exclusion Criteria:

patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560625

Contacts

Contact: Avraham Ishay, MD	97246495556	ishay_av@clalit.org.il
Contact: Rafael Luboshitzky, MD	9726495553	luboshitzky_r@clalit.org.il

Locations

Israel
Endocrine Institute, Haemek medical Center	Recruiting
Afula, Israel, 18101
Principal Investigator: Avraham Ishay, MD

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:

Avraham Ishay, MD

Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel

More Information

Study ID Numbers:	0030-07EMC
Study First Received:	November 18, 2007
Last Updated:	November 18, 2007
ClinicalTrials.gov Identifier:	NCT00560625
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Fluticasone
Epinephrine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009