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

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Idiopathic Pulmonary FibrosisPulmonary Hypertension
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."

Trial Locations (6)

22042

Inova Heart and Vascular Institute, Falls Church

92037

UCSD Medical Center m/c7381, La Jolla

95817

UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program, Sacramento

48109-5853

University of Michigan, Ann Arbor

37232-5735

Vanderbilt University Medical Center, Nashville

75390-8550

UTWS Medical Center Dallas/St. Paul Univ. Hospital, Dallas

Sponsors
All Listed Sponsors
lead

Lung Biotechnology PBC

INDUSTRY

NCT00703339 - Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis | Biotech Hunter | Biotech Hunter