TETON-OLE: Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Sponsor
United Therapeutics (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04905693
Collaborator
(none)
792
3
1
46
264
5.7

Study Details

Study Description

Brief Summary

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

Condition or Disease Intervention/Treatment Phase
  • Drug: Inhaled Treprostinil
  • Device: Treprostinil Ultrasonic Nebulizer
Phase 3

Detailed Description

Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301 or Study RIN-PF-303 to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis (IPF). Following OLE entry, subjects will return at Week 4, Week 12, and every 12 weeks thereafter for up to 6 years or until the subject prematurely discontinues study treatment due an adverse event (AE)/serious adverse event (SAE) or other reason, inhaled treprostinil becomes commercially available for IPF, or the study is discontinued by the Sponsor (whichever is sooner).

Efficacy assessments will include spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) Questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and diffusion capacity of lungs for carbon monoxide (DLCO). Safety assessments will include monitoring for the development of AEs/SAEs, vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. In addition, up to 24 eligible subjects may participate in a PK substudy to evaluate the systemic exposure of treprostinil after inhaled administration.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
792 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open-label ExtensionOpen-label Extension
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inhaled Treprostinil

Treprostinil inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated to a target of 15 breaths QID or until the subject reaches their maximum clinically tolerated dose.

Drug: Inhaled Treprostinil
Inhaled Treprostinil (6 mcg/breath) administered QID
Other Names:
  • Tyvaso
  • Device: Treprostinil Ultrasonic Nebulizer
    Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

    Outcome Measures

    Primary Outcome Measures

    1. Long-term safety and tolerability of inhaled treprostinil in subjects with IPF [Baseline to 6 years]

      Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Subject gives voluntary informed consent to participate in the study.

    2. The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study RIN-PF-303 at the time that the study or study subject was discontinued by the Sponsor.

    3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit and Baseline) and non-lactating, and will abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.

    4. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

    5. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

    Exclusion Criteria:
    1. Subject is pregnant or lactating.

    2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pulmonary Disease Specialists, PA d/b/a PDS Research Kissimmee Florida United States 34741
    2 University of Kansas Medical Center Kansas City Kansas United States 66160
    3 The Lung Research Center, LLC Chesterfield Missouri United States 63017

    Sponsors and Collaborators

    • United Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    United Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04905693
    Other Study ID Numbers:
    • RIN-PF-302
    First Posted:
    May 28, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by United Therapeutics
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022