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

NCT ID: NCT01941225

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic obstructive pulmonary disease Pulmonary vasculature Inhaled iloprost Inhaled prostacyclin Dynamic hyperinflation Oxidative stress Cardiopulmonary exercise testing B-type natriuretic peptide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Nebulized normal saline. Single administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single administration

Inhaled iloprost 5.0 mcg

Single administration

Group Type EXPERIMENTAL

Inhaled iloprost 5.0 mcg

Intervention Type DRUG

Single administration

Interventions

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Inhaled iloprost 5.0 mcg

Single administration

Intervention Type DRUG

Placebo

Single administration

Intervention Type DRUG

Other Intervention Names

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Ventavis Nebulized normal saline

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Matthew Lammi

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew R Lammi, MD

Role: PRINCIPAL_INVESTIGATOR

LSU Health Sciences Center

Locations

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LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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GM104940-50346-S

Identifier Type: -

Identifier Source: org_study_id