Does Inhaled Busedonide or Fluticasone Impair Adrenal Fun... | NCT00560625

Studies
Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

NCT00560625

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Sep 8, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Adrenal Insufficiency

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruiting subjects did not start.

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 18, 2007

First Submission Date that Met QC Criteria

Nov 18, 2007

First Posted Date

Nov 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stimulated serum cortisol levels		within 30 days of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

hospital-based respiratory diseases clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avraham Ishay, MD	Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endocrine Institute, Haemek medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000309	Adrenal Insufficiency

Ancestor Terms

ID	Term
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided