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

Adrenal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140761
• Other study ID #: COPTRIN
• Status: Completed
• Start date: August 17, 2017
• Est. completion date: May 9, 2020

Study information

• Verified date: May 2020
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 9, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency

Locations

Country	Name	City	State
Denmark	Department of Internal medicine, Herlev & Gentofte Universtity Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary Adrenal insufficiency	test for adrenal function by stimulation test	average 1 month
Secondary	Metabolic syndrome	blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition	average 1 month
Secondary	Bone mineral loss	bonemarkers	average 1 month
Secondary	Onset of Diabetes Mellitus		average 1 month
Secondary	Quality of life	test by questionnaires	average 1 month