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Vasoactive Intestinal Peptide in COPD (VIPCOPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464932
First Posted: April 24, 2007
Last Update Posted: April 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of Vienna
  Purpose

This study, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.


Condition Intervention Phase
COPD Pulmonary Hypertension Drug: Vasoactive Intestinal Peptide (VIP) Phase 2

Study Type: Observational
Study Design: Allocation: Random Sample
Time Perspective: Longitudinal
Time Perspective: Prospective

Further study details as provided by Medical University of Vienna:

Estimated Enrollment: 34
Study Start Date: June 2003
Study Completion Date: July 2006
Detailed Description:

Chronic obstructive bronchitis is a chronic inflammatory disease of the airways, which affects as many as 8% of individuals in industrialized nations. There is an increase in the number of woman and men suffering from COPD. Pulmonary hypertension and cor pulmonale are common sequelae of chronic airflow obstruction, but the precise mechanisms of increased vascular resistance are unclear. Potential causes of pulmo-nary hypertension in COPD include emphysematous destruction of the capillary bed, remodeling of pulmonary vessels and hypoxic pulmonary vasoconstriction. This proposal, a new immunomodulatory therapy of COPD with vasoactive intestinal peptide (VIP) was evaluated. Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

34 patients with severe COPD were treated either with VIP inhalation in addition to conventional therapy or inhalation of placebo plus conventional therapy for a period of 3 months. The trial was conducted as a double blind, comparative study with two parallel groups.

In the absence of acute infection or acute worsening of the disease due to other conditions, 2 transbronchial biopsies were collected before treatment, and after 3 months of treat¬ment for assessment of the regulation of a) the immune response, b) the extracellular matrix and c) the epithelial growth. This assessment will be performed in fully equipped and experienced laboratories at the University of Vienna.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed moderate to severe COPD with or without pulmonary hypertension
  • Male and female patients.
  • Aged 18 - 75 years.
  • Written consent.
  • Adequate contraception in female patients of childbearing age.
  • Negative pregnancy test (four-weekly test repetition).

Exclusion Criteria:

  • Lack of consent
  • Pregnancy (four-weekly tests)
  • Lactation
  • Presumed non-cooperativeness
  • Patients outside the stipulated age range
  • Myocardial infarction within the last 12 months
  • Stroke within the last 12 months
  • Malignant diseases in anamnesis
  • Legal incapacity
  • Parallel participation in a clinical trial
  • Parallel participation in a clinical trial within the last 4 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464932


Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Lutz-Henning Block, MD Medical University of Vienna, Department of Pulmology
  More Information

ClinicalTrials.gov Identifier: NCT00464932     History of Changes
Other Study ID Numbers: EK 168/2003
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by Medical University of Vienna:
COPD
Vasoactive Intestinal Peptide
Lung Function

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs


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