Vasoactive Intestinal Peptide in COPD (VIPCOPD)
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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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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 Time Perspective: Prospective |
| 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 Based on preliminary unpublished clinical and experimental results, the course of disease under VIP treatment and the molecular mechanisms involved were assessed.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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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 |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013