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Iloprost in Gas Exchange/Pulm Mechanics in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00561223
First received: November 19, 2007
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
 Drug: iloprost Inhalation
Drug: iloprost

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With COPD

Resource links provided by NLM:

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

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • The alveolar arterial O2 difference [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2 [ Time Frame: One day ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561223

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00561223     History of Changes
Other Study ID Numbers: 12768
Study First Received: November 19, 2007
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Vascular Diseases
Cardiovascular Diseases
 Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013