What the trial was testing
The INCREASE enrolled 326 patients with pulmonary fibrosis. The study was sponsored by United Therapeutics and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was mid-stage testing (phase 2/3). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Patients walked 31 meters farther after 16 weeks of treatment compared to placebo.
The New England journal of medicine · 2021 · NCT02630316
These findings — that patients could walk about 100 feet more in 6 minutes after 16 weeks of treatment — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 326 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with pulmonary fibrosis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This medicine (treprostinil) is FDA-approved for this condition since this large study showed clear benefits. It's inhaled four times daily using a special nebulizer. Talk to your doctor if you have lung scarring with high lung blood pressure about whether this treatment is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open pulmonary fibrosis trials
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
The purposes of this study are to: 1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and 2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib). This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.
Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity. Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.