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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Carmel Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01116063
First received: May 3, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 6 minutes walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Borg dyspnea score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • NT-BNP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Arterial blood gases [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   25 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 3, 2010
Last Updated: May 3, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
COPD, Pulmonary hypertension

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

ClinicalTrials.gov processed this record on September 16, 2014