VIPCOPD: Vasoactive Intestinal Peptide in COPD

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00464932

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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 or Disease	Intervention/Treatment	Phase
COPD Pulmonary Hypertension	Drug: Vasoactive Intestinal Peptide (VIP)

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

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

the epithelial growth. This assessment will be performed in fully equipped and experienced laboratories at the University of Vienna.

Study Design

Study Type:

Observational

Time Perspective:

Prospective

Study Start Date :

Jun 1, 2003

Actual Study Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Lutz-Henning Block, MD, Medical University of Vienna, Department of Pulmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00464932

Other Study ID Numbers:

EK 168/2003

First Posted:

Apr 24, 2007

Last Update Posted:

Apr 24, 2007

Last Verified:

Apr 1, 2007

Keywords provided by , ,

COPD

Vasoactive Intestinal Peptide

Lung Function

Additional relevant MeSH terms:

Hypertension, Pulmonary

Vasoactive Intestinal Peptide

Study Results

No Results Posted as of Apr 24, 2007