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

NCT ID: NCT03140761

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-17

Study Completion Date

2020-05-09

Brief Summary

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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

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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

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Adrenal Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients \> 18 years
* Caucasian classified with COPD
* Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Pradeesh Sivapalan

MD, Phd fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal medicine, Herlev & Gentofte Universtity Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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COPTRIN

Identifier Type: -

Identifier Source: org_study_id

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