NCT01941225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

3.2 years

First QC Date

September 9, 2013

Last Update Submit

December 15, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary diseasePulmonary vasculatureInhaled iloprostInhaled prostacyclinDynamic hyperinflationOxidative stressCardiopulmonary exercise testingB-type natriuretic peptide

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (10)

  • Blood markers of oxidative stress

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

  • Blood markers of inflammation

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

  • Dead space fraction

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

  • B-type natriuretic peptide

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

  • Partial pressure of oxygen

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

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Nebulized normal saline. Single administration

Drug: Placebo

Inhaled iloprost 5.0 mcg

EXPERIMENTAL

Single administration

Drug: Inhaled iloprost 5.0 mcg

Interventions

Inhaled iloprost 5.0 mcgDRUG

Single administration

Also known as: Ventavis
Inhaled iloprost 5.0 mcg
PlaceboDRUG

Single administration

Also known as: Nebulized normal saline
Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health Sciences Center

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Matthew R Lammi, MD

    LSU Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Locations

US(1)