Skip to main content
OpenTrials
Completed

NCT Number: NCT01941225

Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients

The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LSU Health Sciences Center

New Orleans, Louisiana, 70125, United States

About this study

Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 40 years old or older
  • Physician diagnosis of chronic obstructive pulmonary disease
  • 10 or more pack-year smoking history
  • FEV1/FVC <0.70
  • FEV1 35-80% of predicted

Exclusion criteria

  • Acute exacerbation of COPD within the last 30 days
  • Pregnant or breast-feeding
  • Contraindications to cardiopulmonary exercise testing
  • Known intolerance or allergy to iloprost
  • On oral corticosteroids (may be included if off for 7 days prior to testing)
  • Supplemental oxygen need
  • Known inflammatory disease other than COPD
  • Active solid organ/hematologic malignancy

Treatment and study plan

Inhaled iloprost 5.0 mcg

Drug

Single administration

Other names: Ventavis

Placebo

Drug

Single administration

Other names: Nebulized normal saline

Primary outcomes

  1. Dynamic hyperinflation during maximal cardiopulmonary exercise test

    Time frame: Acute response (exercise testing performed 30 minutes after study drug administration)

    Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise

Secondary outcomes

  1. Blood markers of oxidative stress

    Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)

    8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde

  2. Blood markers of inflammation

    Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)

    IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha

  3. Dead space fraction

    Time frame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)

  4. B-type natriuretic peptide

    Time frame: Acute response (measured 30 and 40 minutes after study drug administration)

  5. Partial pressure of oxygen

    Time frame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)

  6. Metabolic and gas exchange parameters during cardiopulmonary exercise test

    Time frame: Acute response (throughout exercise, starting 30 minutes after study drug administration)

  7. Blood cyclic AMP levels

    Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)

  8. Blood iloprost levels

    Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)

  9. Exercise time and external work performed

    Time frame: measured during exercise test 30 minutes after study drug administration

  10. Borg dyspnea and leg scores

    Time frame: During exericse (starting 30 minutes after study drug administration)

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Dec 16, 2016

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.

Published trials that share one or more normalized conditions with this study.