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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled iloprost 5.0 mcg
Placebo
Sponsored by
Louisiana State University Health Sciences Center in New Orleans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Pulmonary vasculature, Inhaled iloprost, Inhaled prostacyclin, Dynamic hyperinflation, Oxidative stress, Cardiopulmonary exercise testing, B-type natriuretic peptide

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LSU Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Inhaled iloprost 5.0 mcg

Arm Description

Nebulized normal saline. Single administration

Single administration

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood markers of oxidative stress
8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde
Blood markers of inflammation
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
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

Full Information

First Posted
September 9, 2013
Last Updated
December 15, 2016
Sponsor
Louisiana State University Health Sciences Center in New Orleans
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1. Study Identification

Unique Protocol Identification Number
NCT01941225
Brief Title
Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
Official Title
Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Pulmonary vasculature, Inhaled iloprost, Inhaled prostacyclin, Dynamic hyperinflation, Oxidative stress, Cardiopulmonary exercise testing, B-type natriuretic peptide

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nebulized normal saline. Single administration
Arm Title
Inhaled iloprost 5.0 mcg
Arm Type
Experimental
Arm Description
Single administration
Intervention Type
Drug
Intervention Name(s)
Inhaled iloprost 5.0 mcg
Other Intervention Name(s)
Ventavis
Intervention Description
Single administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nebulized normal saline
Intervention Description
Single administration
Primary Outcome Measure Information:
Title
Dynamic hyperinflation during maximal cardiopulmonary exercise test
Description
Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise
Time Frame
Acute response (exercise testing performed 30 minutes after study drug administration)
Secondary Outcome Measure Information:
Title
Blood markers of oxidative stress
Description
8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde
Time Frame
Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Title
Blood markers of inflammation
Description
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
Time Frame
Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Title
Dead space fraction
Time Frame
Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
Title
B-type natriuretic peptide
Time Frame
Acute response (measured 30 and 40 minutes after study drug administration)
Title
Partial pressure of oxygen
Time Frame
Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
Title
Metabolic and gas exchange parameters during cardiopulmonary exercise test
Time Frame
Acute response (throughout exercise, starting 30 minutes after study drug administration)
Title
Blood cyclic AMP levels
Time Frame
Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Title
Blood iloprost levels
Time Frame
Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Title
Exercise time and external work performed
Time Frame
measured during exercise test 30 minutes after study drug administration
Title
Borg dyspnea and leg scores
Time Frame
During exericse (starting 30 minutes after study drug administration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Lammi, MD
Organizational Affiliation
LSU Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States

12. IPD Sharing Statement

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

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