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

The Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With COPD

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Intervention / Treatment: Drug: iloprost Inhalation; Drug: iloprost

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Ventavis; Drug: iloprost; inhaled 2.5 mg, repeat times one; Other Names: Ventavis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The alveolar arterial O2 difference	One day

Secondary Outcome Measures

Outcome Measure	Time Frame
PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2	One day

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Gary T Kinasewitz, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): October 31, 2012

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimated): November 20, 2007

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: pulmonary hypertension; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Hypertension; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: 1024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No