Vasoactive Intestinal Peptide in COPD (VIPCOPD)

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00464932
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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

Resource links provided by NLM:


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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464932

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

No publications provided

ClinicalTrials.gov Identifier: NCT00464932     History of Changes
Other Study ID Numbers: EK 168/2003
Study First Received: April 23, 2007
Last Updated: April 23, 2007
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014