Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (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: January 6, 2014
Last verified: January 2014

November 19, 2007
January 6, 2014
September 2006
April 2008   (final data collection date for primary outcome measure)
The alveolar arterial O2 difference [ Time Frame: One day ] [ Designated as safety issue: No ]
The alveolar arterial O2 difference [ Time Frame: One day ]
Complete list of historical versions of study NCT00561223 on ClinicalTrials.gov Archive Site
PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2 [ Time Frame: One day ] [ Designated as safety issue: No ]
PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2 [ Time Frame: One day ]
Not Provided
Not Provided
 
Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension
  • 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
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.

Interventions:
  • Drug: iloprost Inhalation
  • Drug: iloprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00561223
12768
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Gary T Kinasewitz, MD University of Oklahoma
University of Oklahoma
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP