NCT00403650

Brief Summary

This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

November 24, 2006

Last Update Submit

April 10, 2013

Conditions

SarcoidosisPulmonary Arterial Hypertension

Keywords

SarcoidosisDyspneaInterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Change in six minute walk distance

    24 weeks

Secondary Outcomes (4)

  • Quality of life

    24 weeks

  • Respiratory function

    24 weeks

  • Toxicity

    24 weeks

  • Pulmonary artery hemodynamics

    24 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Iloprost

Interventions

IloprostDRUG

Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day

Also known as: Ventavis
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known sarcoidosis 17
  • Age 18 or greater
  • Patients with documented pulmonary hypertension with a PA mean \> 25 mm as measured by cardiac catheterization within six months of entry into the study
  • Patients with dyspnea
  • Six minute walk distance of between 100 to 500 meters
  • Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
  • Patients able to provide written consent

You may not qualify if:

  • Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in the prior 28 days (patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker)
  • Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
  • Patients with World Health Organization (WHO) class IV status
  • Patients who are pregnant or breast feeding
  • Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
  • Significant liver dysfunction not due to sarcoidosis
  • Patients with severe other organ disease felt by investigators to impact survival during the course of the study
  • Patients unable to perform the 6 inhalation treatments required for therapy
  • Patients with \< 90 mm Hg Systolic systemic blood pressure will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

  • Baughman RP, Judson MA, Lower EE, Highland K, Kwon S, Craft N, Engel PJ. Inhaled iloprost for sarcoidosis associated pulmonary hypertension. Sarcoidosis Vasc Diffuse Lung Dis. 2009 Jul;26(2):110-20.

    PMID: 20560291DERIVED

MeSH Terms

Conditions

SarcoidosisPulmonary Arterial HypertensionDyspneaLung Diseases, Interstitial

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Robert P. Baughman, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 24, 2006

First Posted

November 27, 2006

Study Start

November 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

US(1)