Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-18 @ 2:50 PM
Study NCT ID:
NCT03140761
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2017-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and DNA from gene analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-09', 'studyFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Secondary Adrenal insufficiency', 'timeFrame': 'average 1 month', 'description': 'test for adrenal function by stimulation test'}], 'secondaryOutcomes': [{'measure': 'Metabolic syndrome', 'timeFrame': 'average 1 month', 'description': 'blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition'}, {'measure': 'Bone mineral loss', 'timeFrame': 'average 1 month', 'description': 'bonemarkers'}, {'measure': 'Onset of Diabetes Mellitus', 'timeFrame': 'average 1 month'}, {'measure': 'Quality of life', 'timeFrame': 'average 1 month', 'description': 'test by questionnaires'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Insufficiency']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '78 hospitalised patients with exacerbation of COPD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\> 18 years\n* Caucasian classified with COPD\n* Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)\n\nExclusion Criteria:\n\n* Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®\n* Pregnancy or lactation\n* on regular systemic glucocorticoid therapy before admission to the hospital\n* People who are detained under the act on the use of coercion in psychiatry\n* Severe language problems or inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT03140761', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Chronic Obstructive Pulmonary Disease Trial Network, Denmark'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'COPTRIN'}}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Department of Internal medicine, Herlev & Gentofte Universtity Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chronic Obstructive Pulmonary Disease Trial Network, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Phd fellow', 'investigatorFullName': 'Pradeesh Sivapalan', 'investigatorAffiliation': 'Chronic Obstructive Pulmonary Disease Trial Network, Denmark'}}}}