- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01703013
The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases
October 9, 2012 updated by: Martin BRUTSCHE, Cantonal Hospital of St. Gallen
The pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear.
In a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (COPD), the investigators demonstrated a highly significant correlation between the expression level of Defensin-alpha 4 (DEFA4) mRNA in blood and the adrenal function assessed via low-dose ACTH tests.
The aim of this prospective study is to demonstrate that DEFA4 measured both at the mRNA level (RT-PCR) and at the protein level (Western blot/Elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with COPD and pneumonia).
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
75
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)
Description
Inclusion Criteria:
- Patients 18-80 yo
- Patients diagnosed with pneumonia or exacerbated COPD
- Healthy controls 18-80yo
- Signed informed consent
Exclusion Criteria:
- Pregnant or lactating females
- Life threatening severe disease
- Known primary or secondary adrenal insufficiency
- Systemic steroid therapy in the last 8 weeks
- Systemic therapy with opioid
- Systemic therapy with Ketoconazol, Mitotane, Metopyron, Etomidat, Rifampicin
- In healthy controls: relevant respiratory disease or known adrenal insufficiency or indication of infection
- Allergic reaction to ACTH
- Missing informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Study Registration Dates
First Submitted
October 5, 2012
First Submitted That Met QC Criteria
October 9, 2012
First Posted (Estimate)
October 10, 2012
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 9, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSSG-Pneumo-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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