Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464932
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2007-04-23
Brief Title:
Vasoactive Intestinal Peptide in COPD
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIPCOPD
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study a new immunomodulatory therapy of COPD with vasoactive intestinal peptide VIP was evaluated Based on preliminary unpublished clinical and experimental results the course of disease under VIP treatment and the molecular mechanisms involved were assessed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
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
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a new immunomodulatory therapy of COPD with vasoactive intestinal peptide VIP was evaluated Based on preliminary unpublished clinical and experimental results the course of disease under VIP treatment and the molecular mechanisms involved were assessed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 treatment 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
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 treatment 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None