Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
The purpose of this study is to establish single-dose tolerability of inhaled treprostinil sodium in idiopathic pulmonary fibrosis (IPF) patients with pulmonary hypertension, and to explore the acute hemodynamic effects over a range of tolerable doses. The safety and pharmacodynamic information obtained from this study will inform the design and conduct of future studies in inhaled treprostinil sodium in this population.
Idiopathic Pulmonary Fibrosis
Drug: Treprostinil sodium for inhalation
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Dose, Dose-Escalating Study Exploring the Safety, Pharmacokinetics, and Pharmacodynamic Effects of Inhaled Treprostinil Sodium Using the Nebu-Tec OPTINEB Inhalation Device in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis|
- Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events [ Time Frame: 3-5 days ] [ Designated as safety issue: Yes ]Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.
- Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects. [ Time Frame: acute ] [ Designated as safety issue: Yes ]PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.
|Study Start Date:||June 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: Treprostinil sodium for inhalation
- Cohort 1: dosed at 3 breaths (18 mcg)
- Cohort 2: dosed at 6 breaths (36 mcg)
- Cohort 3: dosed at 9 breaths (54 mcg)
- Cohort 4: dosed at 12 breaths (72 mcg)
Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose
The decision to advance to the next cohort will be made after review of all safety information including vital signs, physical examination, clinical laboratory tests, ECGs, and adverse events.
This is Phase 2, multi-center, open-label, four-cohort study in subjects with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF). Each cohort of four subjects will receive a single dose of inhaled treprostinil sodium. Cohorts will be enrolled sequentially, starting with the lowest dose of 18 mcg. Each cohort escalate by 18 mcg increments, resulting in four cohorts of 18, 36, 54, and 72 mcg doses. Decisions to escalate to the next dose cohort will be based upon the data from the previous completed lower dose cohort of four subjects. Approximately 16 subjects are expected to receive study drug,and approximately four center in the United States with expertise in IPF will participate in this study.
|United States, California|
|UCSD Medical Center m/c7381|
|La Jolla, California, United States, 92037|
|UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program|
|Sacramento, California, United States, 95817|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5853|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-5735|
|United States, Texas|
|UTWS Medical Center Dallas/St. Paul Univ. Hospital|
|Dallas, Texas, United States, 75390-8550|
|United States, Virginia|
|Inova Heart and Vascular Institute|
|Falls Church, Virginia, United States, 22042|