Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD) (Iloprost)

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: NCT00561223
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The investigators believe that iloprost will improve gas exchange in COPD patients with pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Drug: iloprost Inhalation Drug: iloprost Not Applicable

Detailed Description:
Pulmonary hypertension and right heart failure can complicate the management of the patient with advanced COPD. Attempts to treat this pulmonary hypertension with systemic vasodilators frequently result in a worsening of ventilation perfusion matching and an increase sense of dyspnea. This study will look at the effect of an FDA approved pulmonary vasodilator, iloprost, on gas exchange and pulmonary mechanics in patients with COPD. Ten clinically stable patients will be enrolled. They will report to the lab on the morning of the study and after an arterial line is placed, pulmonary function measurements and arterial blood gases will be obtained. Iloprost (2.5 mcg via nebulizer) will be administered and the effect upon arterial blood pressure, respiration and arterial saturation will be monitored. Pulmonary function tests (PFTs) and blood gases will be repeated after 30 minutes. Patients who remain clinically stable without evidence of a fall in arterial PO2 or systemic blood pressure would inhale a second dose of 2.5 mcg of iloprost. The patient will be monitored for a minimum of 2 hours after their last dose of iloprost. Primary outcome variable will be the alveolar arterial O2 difference while secondary outcomes will include PAO2, venous admixture, FVC and FEV1, DLCO and ventilatory equivalents for O2 and CO2. All comparisons will be made using Student's t-test with a Bonferroni correction. The number of study patients was chosen on the basis of a power analysis to provide an alpha of 0.05 at a level of 0.9.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With COPD
Study Start Date : September 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1

This study will examine the hypothesis that iloprost maintains and improves ventilation perfusion matching in patients with COPD as reflected by 1) a constant or reduced alveolar to arterial O2 difference as calculated from the measured arterial blood gases obtained before and after iloprost administration, 2) an improvement in the lung diffusing capacity for carbon monoxide that occurs in the absence of a change in spirometry, 3) an improvement in the ventilatory equivalent for oxygen and CO2 measured by expired gas analysis.

It is anticipated that a positive result in this pilot study would lead to a larger long-term study examining the effect of iloprost on gas exchange, exercise tolerance and quality of life in patients with COPD.

Drug: iloprost Inhalation
inhale 2.5 mg, repeat times one
Other Name: Ventavis
Drug: iloprost
inhaled 2.5 mg, repeat times one
Other Name: Ventavis

Primary Outcome Measures :
  1. The alveolar arterial O2 difference [ Time Frame: One day ]

Secondary Outcome Measures :
  1. PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2 [ Time Frame: One day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • FEV1 < 65% of predicted and FEV1 to FVC ratio < 70%
  • Baseline PAO2 while stable between 60-75 mmHg and
  • The ability to provide informed consent

Exclusion Criteria:

  • Clinical instability as evidenced by an acute exacerbation requiring an intensification of therapy and/or the need for hospitalization with the preceding 3 months.
  • Presence of an additional cause of lung disease as suggested by history, clinical or radiographic findings, or pulmonary function tests
  • Presence of left ventricular dysfunction and/or left atrial enlargement by echo, ECHO or catheterization
  • Heparin allergy
  • Pregnancy or breast feeding

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): NCT00561223

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Gary T Kinasewitz, MD University of Oklahoma

Responsible Party: University of Oklahoma Identifier: NCT00561223     History of Changes
Other Study ID Numbers: 12768
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by University of Oklahoma:
chronic obstructive pulmonary disease
pulmonary hypertension

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