Adrenal InsufficiencyNCT03140761
The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
An observational study of Adrenal Insufficiency, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
Trial summary
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 78 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2017to 9 May 2020
- How long will I take part?
- 1 Month
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 78 hospitalised patients with exacerbation of COPD
Who may be able to join
- Adult patients > 18 years
- Caucasian classified with COPD
- Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)
Who cannot join
- Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
- Pregnancy or lactation
- on regular systemic glucocorticoid therapy before admission to the hospital
- People who are detained under the act on the use of coercion in psychiatry
- Severe language problems or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal medicine, Herlev & Gentofte Universtity Hospital
Hellerup, 2900
About this study
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.
Read the detailed description
COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.
- 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.
Secondary Adrenal insufficiency
test for adrenal function by stimulation test
Measured: average 1 month
Secondary outcomes (4)
Metabolic syndrome
blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition
Measured: average 1 month
Bone mineral loss
bonemarkers
Measured: average 1 month
Onset of Diabetes Mellitus
Measured: average 1 month
Quality of life
test by questionnaires
Measured: average 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start17 Aug 2017
- Primary completion1 Jan 2020
- Study completion9 May 2020
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
- 78 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Pradeesh Sivapalan, Chronic Obstructive Pulmonary Disease Trial Network, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140761
- Sponsor's protocol ID
- COPTRIN
- Status last verified
- May 2020
- First submitted
- 17 Apr 2017
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene
- ClinicalTrials.gov ID
- NCT03140761
- Acronym / sponsor ID
- COPTRIN
- Conditions
- Adrenal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 9 May 2020 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.
Detailed description
COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 78 hospitalised patients with exacerbation of COPD
Key inclusion criteria (3 listed)
- Adult patients > 18 years
- Caucasian classified with COPD
- Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)
Key exclusion criteria (5 listed)
- Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
- Pregnancy or lactation
- on regular systemic glucocorticoid therapy before admission to the hospital
- People who are detained under the act on the use of coercion in psychiatry
- Severe language problems or inability to provide written informed consent
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
Secondary Adrenal insufficiency
Time frame: average 1 month
test for adrenal function by stimulation test
4 secondary outcomes
Metabolic syndrome
Time frame: average 1 month
Bone mineral loss
Time frame: average 1 month
Onset of Diabetes Mellitus
Time frame: average 1 month
Quality of life
Time frame: average 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 May 2020. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Secondary Adrenal insufficiency (time frame: average 1 month). 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 12 May 2020.