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Trial record 5 of 61 for:    "Lung Disease" | "Iloprost"

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

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ClinicalTrials.gov Identifier: NCT01941225
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Inhaled iloprost 5.0 mcg Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
Study Start Date : September 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Iloprost

Arm Intervention/treatment
Placebo Comparator: Placebo
Nebulized normal saline. Single administration
Drug: Placebo
Single administration
Other Name: Nebulized normal saline

Experimental: Inhaled iloprost 5.0 mcg
Single administration
Drug: Inhaled iloprost 5.0 mcg
Single administration
Other Name: Ventavis




Primary Outcome Measures :
  1. Dynamic hyperinflation during maximal cardiopulmonary exercise test [ Time Frame: Acute response (exercise testing performed 30 minutes after study drug administration) ]
    Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise


Secondary Outcome Measures :
  1. Blood markers of oxidative stress [ Time Frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) ]
    8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde

  2. Blood markers of inflammation [ Time Frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) ]
    IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha

  3. Dead space fraction [ Time Frame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration) ]
  4. B-type natriuretic peptide [ Time Frame: Acute response (measured 30 and 40 minutes after study drug administration) ]
  5. Partial pressure of oxygen [ Time Frame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise) ]
  6. Metabolic and gas exchange parameters during cardiopulmonary exercise test [ Time Frame: Acute response (throughout exercise, starting 30 minutes after study drug administration) ]
  7. Blood cyclic AMP levels [ Time Frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) ]
  8. Blood iloprost levels [ Time Frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration) ]
  9. Exercise time and external work performed [ Time Frame: measured during exercise test 30 minutes after study drug administration ]
  10. Borg dyspnea and leg scores [ Time Frame: During exericse (starting 30 minutes after study drug administration) ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941225


Locations
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United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70125
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Investigators
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Principal Investigator: Matthew R Lammi, MD LSU Health Sciences Center

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Responsible Party: Matthew Lammi, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT01941225     History of Changes
Other Study ID Numbers: GM104940-50346-S
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans:
Chronic obstructive pulmonary disease
Pulmonary vasculature
Inhaled iloprost
Inhaled prostacyclin
Dynamic hyperinflation
Oxidative stress
Cardiopulmonary exercise testing
B-type natriuretic peptide
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents