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Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

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ClinicalTrials.gov Identifier: NCT00560625
Recruitment Status : Terminated (recruiting subjects did not start.)
First Posted : November 20, 2007
Last Update Posted : September 8, 2016
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:
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 or disease
Adrenal Insufficiency

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: 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.
Study Start Date : May 2007
Primary Completion Date : December 2007
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone
U.S. FDA Resources




Primary Outcome Measures :
  1. stimulated serum cortisol levels [ Time Frame: within 30 days of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00560625


Locations
Israel
Endocrine Institute, Haemek medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Avraham Ishay, MD Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel

ClinicalTrials.gov Identifier: NCT00560625     History of Changes
Other Study ID Numbers: 0030-07EMC
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents