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Vasoactive Intestinal Peptide in COPD (VIPCOPD)

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.
 
ClinicalTrials.gov Identifier: NCT00464932
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : April 24, 2007
Sponsor:
Information provided by:
Medical University of Vienna

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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.

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.

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Study Type : Observational
Enrollment : 34 participants
Time Perspective: Prospective
Study Start Date : June 2003
Actual Study Completion Date : July 2006

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
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Principal Investigator: Lutz-Henning Block, MD Medical University of Vienna, Department of Pulmology
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ClinicalTrials.gov Identifier: NCT00464932    
Other Study ID Numbers: EK 168/2003
First Posted: April 24, 2007    Key Record Dates
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:
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Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs