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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941225
• Other study ID #: GM104940-50346-S
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2013
• Last updated: December 15, 2016
• Start date: September 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inhaled iloprost 5.0 mcg
Single administration
• Placebo
Single administration

Locations

Country	Name	City	State
United States	LSU Health Sciences Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Blood markers of oxidative stress	8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde	Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)	No
Secondary	Blood markers of inflammation	IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha	Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)	No
Secondary	Dead space fraction		Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)	No
Secondary	B-type natriuretic peptide		Acute response (measured 30 and 40 minutes after study drug administration)	No
Secondary	Partial pressure of oxygen		Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)	Yes
Secondary	Metabolic and gas exchange parameters during cardiopulmonary exercise test		Acute response (throughout exercise, starting 30 minutes after study drug administration)	No
Secondary	Blood cyclic AMP levels		Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)	No
Secondary	Blood iloprost levels		Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)	No
Secondary	Exercise time and external work performed		measured during exercise test 30 minutes after study drug administration	No
Secondary	Borg dyspnea and leg scores		During exericse (starting 30 minutes after study drug administration)	No