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NCT00560625 Clinical Trial

Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

Adrenal Insufficiency Clinical Trial

Official title:
Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-pituitary-adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00560625
Other study ID # 0030-07EMC
Secondary ID
Status Terminated
Phase N/A
First received November 18, 2007
Last updated September 7, 2016
Start date May 2007
Est. completion date December 2008

Study information
Verified date September 2016
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date December 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Endocrine Institute, Haemek medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary stimulated serum cortisol levels within 30 days of treatment
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