Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnited Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject gives voluntary informed consent to participate in the study.
Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
Clinically significant decline in % predicted FVC based on ≥10% relative decline
Disqualifiers
Subject is pregnant or lactating.
Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC <0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
Subject has a diagnosis of IPF.
Subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
DrugPlacebo administered QID
Inhaled Treprostinil
DrugInhaled treprostinil (6 mcg/breath) administered QID
Treprostinil Ultrasonic Nebulizer
DeviceTreprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
Treatment groups
698 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 2 interventions
Group B: Inhaled TreprostinilExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Week 52Secondary outcomes
1
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.
Time frame
Baseline to Week 522
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.
Time frame
Baseline to Week 523
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.
Time frame
Week 524
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.
Time frame
Baseline to Week 52Sponsors and contacts
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Source ClinicalTrials.gov