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

NCT00703339 | Terminated Phase 2 Results DMC

• 1 other identifier: TREINH-IPF-201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

Brief 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

Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension

Keywords

fibrosis, pulmonary; hypertension, pulmonary; exercise, aerobic

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  3-5 days

Secondary Outcomes (1)

• Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.

  acute

Interventions

Treprostinil sodium for inhalation DRUG

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.

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Male or female
• Diagnosis of IPF
• Investigator diagnosis based on history, physical examination, HRCT,and pulmonary function testing
• Clinical symptoms of IPF for at least three months prior to Visit 1
• High Resolution CT scan showing definite or probable IPF (any time in the past). Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan must also be present (at any time in the past)
• Surgical lung biopsy showing usual interstitial pneumonia, or transbronchial lung biopsy that was not diagnostic of an alternative condition. For patients younger than 50 years, a surgical lung biopsy is required (at any time in the past)
• FVC ≥ 30 % and \< 70% of predicted value within three months prior to Visit 1
• DLCO ≥ 15% and \<70% of predicted value within three months prior to Visit 1.
• Diagnosis of PH
• Previously documented radiographic or echocardiographic findings suggestive of pulmonary hypertension
• Prior right heart catheterization diagnostic of pre-capillary pulmonary hypertension. \[The presence of pre-capillary pulmonary hypertension will be verified by right heart catheterization during Study Visit 3, before enrollment and administration of study drug\].
• No changes in concomitant medications prescribed to treat PAH or IPF for 30 days to Visit 1
• Females of childbearing potential may participate only if they are not currently pregnant or lactating and are either one of the following:
• Surgically sterile

You may not qualify if:

• History of known or suspected pulmonary embolism or deep venous thrombosis
• Clinical evidence of left-sided heart disease
• Presence of atrial fibrillation (determined from 12 lead ECG at Visit 1 or 2)
• Other medical condition or drug exposure known to be associated with pulmonary fibrosis (e.g., rheumatoid arthritis, lupus, scleroderma, etc.) or pulmonary arterial hypertension (e.g., connective tissue disease, congenital heart disease, portal hypertension, HIV infection, drug and toxins, etc.)
• Upper or lower respiratory infection within 30 days prior to Visit 1
• Hospitalization for respiratory illness within 30 days prior to Visit 1
• Diagnosis of any other clinically significant illness that, in the opinion of the investigator, might put the subject at risk of harm from participation in the study or might adversely effect the interpretation of the study data. (e.g., significant liver or kidney disease, etc.)
• History of recurrent symptoms that might, in the opinion of the investigator, adversely effect the interpretation of the study data (e.g., severe headaches, diarrhea, jaw pain, syncope, nausea,vomiting, etc.)
• Current treatment with any medication that is approved by the US FDA to treat pulmonary hypertension (e.g., epoprostenol(Flolan), treprostinil (Remodulin), iloprost (Ventavis), bosentan(Tracleer), ambrisentan (Letairis), sildenafil (Revatio), etc.,), or tadalafil (Cialis)
• Current treatment with an anticoagulant
• A reactive screen for hepatitis B surface antigen, or the hepatitis C antibody, or HIV antibody as tested at Visit 1.
• Use of any inhaled tobacco products or significant history of drug abuse within 90 days prior to Visit 1
• The subject has an echocardiogram performed at Visit 2 that demonstrate findings that are indicative of left ventricular or valvular disease. Findings that will be considered evidence of left ventricular or valvular disease, and therefore exclude the subject from proceeding to Visit 3 are any of the following:
• LVEF \< 55%
• Moderate to Severe mitral regurgitation or aortic regurgitation

Sponsors & Collaborators

• Lung Biotechnology PBC: lead

Study Sites (6)

UCSD Medical Center m/c7381

La Jolla, California, 92037, United States

Location

UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program

Sacramento, California, 95817, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5853, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5735, United States

Location

UTWS Medical Center Dallas/St. Paul Univ. Hospital

Dallas, Texas, 75390-8550, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Hypertension, Pulmonary; Pulmonary Fibrosis; Motor Activity

Interventions

treprostinil; Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

Study was closed on December 31, 2009 and enrolled a total of 1 patient with complete assessment and 4 screened failures. The reason for the closure was lack of enrollment. No data will be analyzed.

Results Point of Contact

• Title: Rosa Negro-Vilar
• Organization: Lung Rx

rnegrovilar@lungrx.com

240-821-1881

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 11, 2018
• Results First Posted: May 10, 2012

Record last verified: 2012-05

Locations

US (6)