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

Information source: Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Inhaled iloprost 5.0 mcg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Louisiana State University Health Sciences Center in New Orleans

Official(s) and/or principal investigator(s):
Matthew R Lammi, MD, Principal Investigator, Affiliation: LSU Health Sciences Center

Overall contact:
Matthew R Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu

Summary

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.

Clinical Details

Official title: Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Dynamic hyperinflation during maximal cardiopulmonary exercise test

Secondary outcome:

Blood markers of oxidative stress

Blood markers of inflammation

Dead space fraction

B-type natriuretic peptide

Partial pressure of oxygen

Metabolic and gas exchange parameters during cardiopulmonary exercise test

Blood cyclic AMP levels

Blood iloprost levels

Exercise time and external work performed

Borg dyspnea and leg scores

Detailed description: 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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Matthew R Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu

LSU Health Sciences Center, New Orleans, Louisiana 70125, United States; Recruiting
Matthew R Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu
Matthew R Lammi, MD, Principal Investigator
Bennett deBoisblanc, MD, Sub-Investigator
Hamid Boulares, PhD, Sub-Investigator
Brianne Aiello, MD, Sub-Investigator
Andy Pellett, PhD, Sub-Investigator
Additional Information

Starting date: September 2013
Last updated: January 12, 2015

Page last updated: August 23, 2015

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