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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iloprost Inhalation
iloprost
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, pulmonary hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

The alveolar arterial O2 difference

Secondary Outcome Measures

PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2

Full Information

First Posted
November 19, 2007
Last Updated
June 5, 2019
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00561223
Brief Title
Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
Iloprost
Official Title
The Effect of Iloprost on Gas Exchange and Pulmonary Mechanics in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Keywords
chronic obstructive pulmonary disease, pulmonary hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
iloprost Inhalation
Other Intervention Name(s)
Ventavis
Intervention Description
inhale 2.5 mg, repeat times one
Intervention Type
Drug
Intervention Name(s)
iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
inhaled 2.5 mg, repeat times one
Primary Outcome Measure Information:
Title
The alveolar arterial O2 difference
Time Frame
One day
Secondary Outcome Measure Information:
Title
PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary T Kinasewitz, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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

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