- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00703339
Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92037
- UCSD Medical Center m/c7381
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Sacramento, California, United States, 95817
- UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program
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Michigan
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Ann Arbor, Michigan, United States, 48109-5853
- University of Michigan
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Tennessee
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Nashville, Tennessee, United States, 37232-5735
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, United States, 75390-8550
- UTWS Medical Center Dallas/St. Paul Univ. Hospital
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Heart and Vascular Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 35 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
- At least 1 year post-menopausal
- Practicing an acceptable method of birth control for at least 30 prior to the Visit 1 with plans to continue this method for the duration of their participation in the study.
An echocardiogram will be performed at Visit 2. Only those subjects with Visit 2 echocardiographic findings that strongly suggest the presence of pulmonary hypertension, will proceed to Visit 3. Acceptable findings include any of the following:
- TR velocity greater than 3.5 m/sec
- TR velocity greater than 3.0 m/sec with right ventricular enlargement or dysfunction
A right heart catheterization will be performed at Visit 3. Only those subjects with Visit 3 right heart catheterization findings that establish the presence of pulmonary hypertension will proceed to enrollment and study drug administration. Acceptable findings must include all of the followings:
- mean PA pressure equal or greater than 25 mm HG
- pulmonary capillary wedge pressure equal or less than 15 mm Hg
- pulmonary vascular resistance greater than 3 mmHg/min
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- 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
- Any mitral stenosis or aortic stenosis
- Grade 2 or 3 diastolic dysfunction by Doppler
- Use of any investigational drug, or participation in any investigational study within the 30 days prior to Visit 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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3-5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.
Time Frame: acute
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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.
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acute
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TREINH-IPF-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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