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

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.

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

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.

Clinical Trials on Adrenal Insufficiency

3
Subscribe