Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)

NCT00561223 | Completed DMC

• 1 other identifier: 1024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators believe that iloprost will improve gas exchange in COPD patients with pulmonary hypertension.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Keywords

chronic obstructive pulmonary disease; pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• The alveolar arterial O2 difference

  One day

Secondary Outcomes (1)

• PaO2, vital capacity, FEV1, DLCO, ventilatory equivalents for O2 and CO2

  One day

Study Arms (1)

1

EXPERIMENTAL

This study will examine the hypothesis that iloprost maintains and improves ventilation perfusion matching in patients with COPD as reflected by 1) a constant or reduced alveolar to arterial O2 difference as calculated from the measured arterial blood gases obtained before and after iloprost administration, 2) an improvement in the lung diffusing capacity for carbon monoxide that occurs in the absence of a change in spirometry, 3) an improvement in the ventilatory equivalent for oxygen and CO2 measured by expired gas analysis. It is anticipated that a positive result in this pilot study would lead to a larger long-term study examining the effect of iloprost on gas exchange, exercise tolerance and quality of life in patients with COPD.

Drug: iloprost Inhalation; Drug: iloprost

Interventions

iloprost Inhalation DRUG

inhale 2.5 mg, repeat times one

Also known as: Ventavis

1

iloprost DRUG

inhaled 2.5 mg, repeat times one

Also known as: Ventavis

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FEV1 \< 65% of predicted and FEV1 to FVC ratio \< 70%
• Baseline PAO2 while stable between 60-75 mmHg and
• The ability to provide informed consent

You may not qualify if:

• Clinical instability as evidenced by an acute exacerbation requiring an intensification of therapy and/or the need for hospitalization with the preceding 3 months.
• Presence of an additional cause of lung disease as suggested by history, clinical or radiographic findings, or pulmonary function tests
• Presence of left ventricular dysfunction and/or left atrial enlargement by echo, ECHO or catheterization
• Heparin allergy
• Pregnancy or breast feeding

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Gary T Kinasewitz, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: October 31, 2012
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

US (1)