Clinical trial NCT01941225: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2013-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Dynamic hyperinflation during maximal cardiopulmonary exercise test
timeFrame: Acute response (exercise testing performed 30 minutes after study drug administration)
Secondary outcomes:
measure: Blood markers of oxidative stress
timeFrame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
measure: Blood markers of inflammation
timeFrame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
measure: Dead space fraction
timeFrame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
measure: B-type natriuretic peptide
timeFrame: Acute response (measured 30 and 40 minutes after study drug administration)
measure: Partial pressure of oxygen
timeFrame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
measure: Metabolic and gas exchange parameters during cardiopulmonary exercise test
timeFrame: Acute response (throughout exercise, starting 30 minutes after study drug administration)
measure: Blood cyclic AMP levels
timeFrame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
measure: Blood iloprost levels
timeFrame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
measure: Exercise time and external work performed
timeFrame: measured during exercise test 30 minutes after study drug administration
measure: Borg dyspnea and leg scores
timeFrame: During exericse (starting 30 minutes after study drug administration)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
affiliation: LSU Health Sciences Center
name: Matthew R Lammi, MD
role: PRINCIPAL_INVESTIGATOR
References: