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

NCT01116063 | Unknown Phase 4

• 1 other identifier: COPDVEN 2009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Pulmonary vascular resistance

  6 months

Secondary Outcomes (4)

• 6 minutes walking test

  6 months

• Borg dyspnea score

  6 months

• NT-BNP

  6 months

• Arterial blood gases

  6 months

Study Arms (1)

Single arm open label

EXPERIMENTAL

All patients will receive the study drugs and will be evaluated

Drug: Inhaled iloprost

Interventions

Inhaled iloprost DRUG

Inhalation Initial: 2.5 mcg/dose; if tolerated, increase to 5 mcg/dose; administer 6 times daily

Also known as: Brand name - Ventavis

Single arm open label

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with COPD and increased SPAP \>55 on echocardiogram will be screened for the study.
• 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.
• Diagnosis of COPD according to GOLD guidelines
• The patient can read, understand and sign the informed consent.

You may not qualify if:

• \. Other identified cause for pulmonary hypertension

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Pulmoanry Division, Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yochai Adir, MD

  Pulmoanry Division, Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yochai aDIR, MD

CONTACT

972-4-8250517; yochaiad@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 4, 2010

Record last verified: 2010-05

Locations

IL (1)