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Inhaled Iloprost for Disproportionate Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease (COPD) (COPDVEN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Carmel Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01116063
First Posted: May 4, 2010
Last Update Posted: May 4, 2010
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.
Information provided by:
Carmel Medical Center
  Purpose

Pulmonary hypertension is frequently present in COPD and it is generally limited to a mild increase in mean pulmonary artery pressure. However some COPD patients are characterized by higher levels of mPAP at rest, fulfilling the definition of moderate or severe PH disproportionate PH .

In these patients the elevated pulmonary pressures adversely affect the prognosis.At the present time the evidence for the the use of specific pulmonary vasodilators in the management of these patients are scarce and cannot be recommended.the aim of this study is to evaluate the medium term efficacy and safety of the inhaled prostacyclin stable analog, iloprost in patients with COPD and moderate to severe pulmonary hypertension


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled iloprost Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Iloprost for Disproportionate Pulmonary Hypertension in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Pulmonary vascular resistance [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 6 minutes walking test [ Time Frame: 6 months ]
  • Borg dyspnea score [ Time Frame: 6 months ]
  • NT-BNP [ Time Frame: 6 months ]
  • Arterial blood gases [ Time Frame: 6 months ]

Estimated Enrollment: 15
Study Start Date: May 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm open label
All patients will receive the study drugs and will be evaluated
Drug: Inhaled iloprost
Inhalation Initial: 2.5 mcg/dose; if tolerated, increase to 5 mcg/dose; administer 6 times daily
Other Name: Brand name - Ventavis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with COPD and increased SPAP >55 on echocardiogram will be screened for the study.
  2. Patients with normal wedge pressure ( [PCWP] ≤ 15 mm Hg), mean PAP ≥ 35 mm Hg and a pulmonary vascular resistance (PVR- 3.0 wood unit)on right heart catheterization.
  3. Diagnosis of COPD according to GOLD guidelines
  4. The patient can read, understand and sign the informed consent.

Exclusion Criteria:

1. Other identified cause for pulmonary hypertension

  Contacts and Locations
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): NCT01116063


Contacts
Contact: Yochai aDIR, MD 972-4-8250517 yochaiad@clalit.org.il

Locations
Israel
Pulmoanry Division, Carmel Medical Center Not yet recruiting
Haifa, Israel
Contact: Yochai Adir, MD    972-4-8250517    yochaiad@clalit.org.il   
Principal Investigator: Yochai Adir, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yochai Adir, MD Pulmoanry Division, Carmel Medical Center
  More Information

Responsible Party: Yochai Adir, Director pulmonary hypertesnion service, Pulmonary divison Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01116063     History of Changes
Other Study ID Numbers: COPDVEN 2009
First Submitted: May 3, 2010
First Posted: May 4, 2010
Last Update Posted: May 4, 2010
Last Verified: May 2010

Keywords provided by Carmel Medical Center:
COPD, Pulmonary hypertension

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents