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Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00560625
First received: November 18, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

No publications provided

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

Additional relevant MeSH terms:
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013