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
Study to Enable New Diagnostics for Pulmonary Microbes in People With CF
Sputum culture has been the best approach to detect harmful bacteria in the lungs of people with cystic fibrosis (CF). With the widespread use of new CF therapies (like Trikafta and Alyftrak), it is more difficult for people with CF to produce sputum even though they still have harmful bacteria in their lungs. The SEND-CF study is being done to see if there are other ways to detect harmful bacteria in the lungs.
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
ARCT-032-02 is a Phase 2, open-label, multicenter, multiple-ascending dose study of ARCT-032 in adults with CF who are not eligible for CFTR modulator therapy or are not taking CFTR modulators due to drug intolerance, poor response, or lack of access to modulators.