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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
Study details:
Study RIN-PF-305 is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID.
Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52. Efficacy assessments include spirometry (forced vital capacity \[FVC\]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), 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 lung diffusion capacity (DLCO).
Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters. Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-30
Primary completion: 2027-11-01
Study completion finish: 2027-11-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05943535
Intervention or treatment
DRUG: Placebo
DRUG: Inhaled Treprostinil
DEVICE: Treprostinil Ultrasonic Nebulizer
Conditions
- • Progressive Pulmonary Fibrosis
- • Interstitial Lung Disease
Find a site
Closest Location:
Institute for Respiratory Health
Research sites nearby
Select from list below to view details:
Institute for Respiratory Health
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
EXPERIMENTAL: Inhaled Treprostinil
| DRUG: Inhaled Treprostinil
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in Absolute FVC from Baseline to Week 52 | The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. | Baseline to Week 52 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Time to First Clinical Worsening | Clinical worsening is monitored from randomization until 1 of the following criteria are met: death (all causes), hospitalization due to a respiratory indication, or ≥10% relative decline in % predicted FVC. | Baseline to Week 52 |
Time to First Acute Exacerbation of ILD | An exacerbation of ILD is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality. | Baseline to Week 52 |
Overall Survival at Week 52 | Vital status will be assessed for all subjects at Week 52, including those who discontinue the study prematurely or who withdraw consent. | Week 52 |
Change in % Predicted FVC from Baseline to Week 52 | The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Percent predicted FVC is calculated based on factors such as race, sex, age, height, and weight. | Baseline to Week 52 |
Change in K-BILD Questionnaire Score from Baseline to Week 52 | The K-BILD is a self-administered, 15-item questionnaire validated for patients with ILD consisting of 3 domains (breathlessness and activities, psychological, and chest symptoms). | Baseline to Week 52 |
Change in DLCO from Baseline to Week 52 | The DLCO measurement measures how well oxygen moves from the lungs to the blood. | Baseline to Week 52 |
Frequently Asked Questions
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