NCT00464932

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed. 34 patients with severe COPD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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

April 23, 2007

Last Update Submit

April 23, 2007

Conditions

COPDPulmonary Hypertension

Keywords

COPDVasoactive Intestinal PeptideLung Function

Interventions

Vasoactive Intestinal Peptide (VIP)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypertension, Pulmonary

Interventions

Vasoactive Intestinal Peptide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Lutz-Henning Block, MD

    Medical University of Vienna, Department of Pulmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

June 1, 2003

Study Completion

July 1, 2006

Last Updated

April 24, 2007

Record last verified: 2007-04