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Idiopathic Pulmonary FibrosisPhase 2NCT00703339

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

A Phase 2 study testing Treprostinil sodium for inhalation in people with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension, run by Lung Biotechnology PBC at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
Treprostinil sodium for inhalation
How many people
1 participants
Where
6 sitesUnited States
Study dates
Jun 2008to Dec 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-5853

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

    Dallas, Texas, 75390-8550

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

  • UCSD Medical Center m/c7381

    La Jolla, California, 92037

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5735

  • UC Davis Medical Center/Advanced Lung Disease and LungTransplant Program

    Sacramento, California, 95817

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Treprostinil sodium for inhalation
Keywords
fibrosis, pulmonary, hypertension, pulmonary, exercise, aerobic
Medical subject headings
Idiopathic Pulmonary Fibrosis, Hypertension, Pulmonary, Pulmonary Fibrosis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treprostinil sodium for inhalationDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3-5 days

Secondary outcomes (1)

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

    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.

    Measured: acute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Why it stopped: Lack of enrollment to the trial. Very difficult population to recruit.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00703339
Sponsor's protocol ID
TREINH-IPF-201
Status last verified
May 2012
First submitted
19 Jun 2008
Last updated
11 May 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treprostinil sodium for inhalation in people with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension, run by Lung Biotechnology PBC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00703339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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