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800 Participants NeededMy employer runs this trial

Treprostinil Palmitil for Idiopathic Pulmonary Fibrosis

(PALM-PPF Trial)

IM
Overseen ByInsmed Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Insmed Incorporated
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this study is to evaluate the effect of 52 weeks of once daily treatment with TPIP compared with placebo on lung function in adults with PPF.

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Insmed Incorporated

Are You a Good Fit for This Trial?

This trial is for adults with progressive pulmonary fibrosis who have shown worsening lung function or symptoms, confirmed by scans. Participants must have a certain level of lung capacity and either be on stable antifibrotic treatment or not planning to start such treatment during the study.

Inclusion Criteria

Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin at Screening
Forced Vital Capacity ≥45% predicted at Screening
I have not used antifibrotic medication for at least 8 weeks and do not plan to start.
See 5 more

Exclusion Criteria

I have not needed treatment for serious pulmonary hypertension recently.
Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7 and less than age-adjusted lower limit of normal at Screening
I have been diagnosed with idiopathic pulmonary fibrosis.
See 8 more

What Are the Treatments Tested in This Trial?

Interventions

  • Treprostinil Palmitil Inhalation Powder

Trial Overview

The study compares a new inhaled medication called Treprostinil Palmitil Inhalation Powder (TPIP) taken once daily for 52 weeks against a placebo to see if it helps improve lung function in people with progressive pulmonary fibrosis.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treprostinil Palmitil Inhalation Powder (TPIP)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Insmed Incorporated

Lead Sponsor

Trials
44
Recruited
7,600+

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