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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00464932 |
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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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 |
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COPD Pulmonary Hypertension |
Drug: Vasoactive Intestinal Peptide (VIP) |
Phase II |
Study Type: | Observational |
Study Design: | Longitudinal, Random Sample, Prospective Study |
Estimated Enrollment: | 34 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2006 |
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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EK 168/2003 |
Study First Received: | April 23, 2007 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00464932 |
Health Authority: | Austria: Ethikkommission |
COPD Vasoactive Intestinal Peptide Lung Function |
Lung Diseases, Obstructive Vasoactive Intestinal Peptide Respiratory Tract Diseases Hypertension, Pulmonary |
Lung Diseases Vascular Diseases Pulmonary Disease, Chronic Obstructive Hypertension |
Vasodilator Agents Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents Cardiovascular Diseases |
Cardiovascular Agents Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |