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Completed

NCT Number: NCT00561223

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloprost inhalation

Drug

inhale 2.5 mg, repeat times one

Other names: Ventavis

ILOPROST

Drug

inhaled 2.5 mg, repeat times one

Other names: Ventavis

Primary outcomes

  1. The alveolar arterial O2 difference

    Time frame: One day

Secondary outcomes

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

    Time frame: One day

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: Iloprost

Important dates

Study start
2006
Primary completion
2008
Study completion
2012
First posted
Nov 20, 2007
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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