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

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. Identifier: NCT01116063
Recruitment Status : Unknown
Verified May 2010 by Carmel Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2010
Last Update Posted : May 4, 2010
Information provided by:
Carmel Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled iloprost Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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
Study Start Date : May 2010
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 6 minutes walking test [ Time Frame: 6 months ]
  2. Borg dyspnea score [ Time Frame: 6 months ]
  3. NT-BNP [ Time Frame: 6 months ]
  4. Arterial blood gases [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01116063

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Contact: Yochai aDIR, MD 972-4-8250517

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Pulmoanry Division, Carmel Medical Center
Haifa, Israel
Contact: Yochai Adir, MD    972-4-8250517   
Principal Investigator: Yochai Adir, MD         
Sponsors and Collaborators
Carmel Medical Center
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Principal Investigator: Yochai Adir, MD Pulmoanry Division, Carmel Medical Center
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Responsible Party: Yochai Adir, Director pulmonary hypertesnion service, Pulmonary divison Carmel Medical Center Identifier: NCT01116063    
Other Study ID Numbers: COPDVEN 2009
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: May 2010
Keywords provided by Carmel Medical Center:
COPD, Pulmonary hypertension
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents