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The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

This study is not yet open for participant recruitment.
Verified October 2012 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Martin BRUTSCHE, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01703013
First received: October 5, 2012
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition
Adrenal Insufficiency
Inflammatory Lung Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Significance of Defensin Alpha 4 in the Pathophysiology of the Adrenal Insufficiency in Inflammatory Lung Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Biospecimen Retention:   Samples With DNA

Blood leukocytes, serum


Estimated Enrollment: 75
Study Start Date: January 2013
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pneumonia patients (n=30) COPD patients (n=30) Healthy controls (n=15)

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Martin BRUTSCHE, Prof., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01703013     History of Changes
Other Study ID Numbers: KSSG-Pneumo-0001
Study First Received: October 5, 2012
Last Updated: October 9, 2012
Health Authority: Switzerland: Ethics Committee of the Canton St. Gallen

Keywords provided by Cantonal Hospital of St. Gallen:
Demonstrate that DEFA4 is a reliable biomarker for the prediction of adrenal insufficiency

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Lung Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Respiratory Tract Diseases
Defensins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013