Vasoactive Intestinal Peptide in COPD

COPD Clinical Trial

— VIPCOPD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464932
• Other study ID #: EK 168/2003
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2007
• Last updated: April 23, 2007
• Start date: June 2003
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Random Sample, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• COPD
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Vasoactive Intestinal Peptide (VIP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna