NCT00560625

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

November 18, 2007

Last Update Submit

September 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • stimulated serum cortisol levels

    within 30 days of treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital-based respiratory diseases clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Institute, Haemek medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Avraham Ishay, MD

    Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2007

First Posted

November 20, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations