Inhaled therapy aims to slow the march of progressive pulmonary fibrosis

NCT ID NCT07805785

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 3 trial tests an inhaled drug called treprostinil palmitil in adults with progressive pulmonary fibrosis, a condition where lung scarring worsens over time despite standard care. Participants inhale the drug or a placebo once daily for 52 weeks. Researchers measure whether the drug slows the decline in lung function, delays worsening events, and affects survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Treprostinil palmitil inhalation powder, an experimental drug inhaled once daily using a dry powder inhaler
What this could lead to
If it works, this could become a new treatment to slow the loss of lung function in people with progressive pulmonary fibrosis, potentially delaying disease worsening and improving quality of life.
What could go wrong
This is a phase 3 trial, but the drug may still fail to show a benefit or cause side effects. The results will need to be confirmed before any approval, and not all patients may respond the same way.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Radiologic evidence of pulmonary fibrosis of \>10% extent on high-resolution computed tomography (HRCT) in the previous 12 months. * Diagnosis of interstitial lung disease (ILD) (other than idiopathic pulmonary fibrosis \[IPF\]) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator: * Clinically significant decline in % predicted Forced Vital Capacity (FVC) based on ≥10% relative decline * Decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms * Decline in % predicted FVC based on ≥5% to \<10% relative decline combined with an increasing extent of fibrotic changes on chest imaging * Worsening of respiratory symptoms and increasing extent of fibrotic changes on chest imaging * Forced Vital Capacity ≥45% predicted at Screening. * Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin at Screening. * Participants may be either: * On stable therapy (defined as no dose changes in the prior 12 weeks) with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 12 weeks prior to Screening and during the screening period and are planning to stay on this background treatment throughout the study. Combination therapy with more than 1 approved antifibrotic agent is not allowed. Or * Not on treatment with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 8 weeks prior to Screening and during the screening period (ie, either antifibrotic-treatment-naïve or previously discontinued) and do not plan to start or restart antifibrotic treatment during the study. * If treated with rituximab, must be on it for at least 6 months before Screening and in the Investigator's clinical opinion must be refractory to the current regimen. If treated with other immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids), need to be on treatment for at least 12 weeks before Screening and in the investigator's clinical opinion must be refractory to the current regimen. Exclusion Criteria: * Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) \<0.7 and less than the age-adjusted lower limit of normal at Screening. * Diagnosis of idiopathic pulmonary fibrosis (IPF). * Diagnosis of combined pulmonary fibrosis and emphysema. * Extent of emphysema greater than fibrosis on HRCT within 1 year prior to Screening or during the screening period confirmed by central overread. * Acute ILD exacerbation within 90 days prior to Screening or during the screening period (investigator-determined). If hospitalized for a respiratory indication, participants must have been discharged more than 90 days prior to Screening to be eligible. * Acute respiratory infection (eg, COVID-19, influenza, pneumonia) within 30 days prior to Screening or during the Screening period. * Acute pulmonary embolism within 90 days prior to Screening. * Prior TPIP exposure or participation in other clinical trials involving the study drug, TPIP. * Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine). * History of clinically significant pulmonary hypertension (PH) (ie, pulmonary hypertension requiring medical treatment) or the participant has received any PH-approved therapy, including prostacyclin analogs (eg, beraprost, epoprostenol, iloprost, or treprostinil; except for acute vasoreactivity testing), prostacyclin receptor (IP receptor) agonists (eg, selexipag), endothelin receptor antagonists (eg, ambrisentan, bosentan, or macitentan), activin signaling inhibitors (eg, sotatercept), phosphodiesterase type 5 inhibitors (PDE5-Is; eg, sildenafil, tadalafil), or soluble guanylate cyclase stimulators (eg, riociguat) within 60 days prior to Screening or during the screening period. As needed use of a PDE5-I for erectile dysfunction is permitted, provided that no doses are taken within 48 hours prior to any study-related efficacy assessments. * Any physical limitation that would impair the participant's use of the inhaler device or ability to participate in spirometry and/or DLCO assessment. Note: Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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