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Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

NCT00703339 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-05-11

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Treprostinil sodium for inhalation

Administration of inhaled treprostinil sodium 0.6 mg/ml in 3mL ampoules Duration of Treatment: single dose Dose: * 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) 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.

Sponsors & Collaborators

  • Lung Biotechnology PBC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703339 on ClinicalTrials.gov