Adrenal InsufficiencyNCT00560625
Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?
An observational study of Adrenal Insufficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital-based respiratory diseases clinic
Who may be able to join
- patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks
Who cannot join
- patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-pituitary-adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.
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.
Read the 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.
- Conditions
- Adrenal Insufficiency
- Medical subject headings
- Adrenal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
stimulated serum cortisol levels
Measured: within 30 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2007
- Study completionDec 2008
Why it stopped: recruiting subjects did not start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Avraham Ishay, MD, Principal investigator, Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560625
- Sponsor's protocol ID
- 0030-07EMC
- Status last verified
- Sep 2016
- First submitted
- 18 Nov 2007
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-pituitary-adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.
- ClinicalTrials.gov ID
- NCT00560625
- Acronym / sponsor ID
- 0030-07EMC
- Conditions
- Adrenal Insufficiency
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting subjects did not start.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital-based respiratory diseases clinic
Key inclusion criteria (1 listed)
- patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks
Key exclusion criteria (1 listed)
- patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stimulated serum cortisol levels
Time frame: within 30 days of treatment
Results and safety
The study was stopped early (reason given: recruiting subjects did not start.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avraham Ishay, MD principal investigator
Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruiting subjects did not start.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stimulated serum cortisol levels (time frame: within 30 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.