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
Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg QID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.
Study on the Efficacy of Quercetin Intake in Patients With Fibrotic Interstitial Lung Diseases.
Fibrotic interstitial lung diseases (F-ILDs), including both idiopathic pulmonary fibrosis (IPF) and non-IPF, are chronic and progressive lung diseases characterized by excessive scarring of lung tissue, leading to declining lung function, respiratory failure, and high mortality, despite the currently approved antifibrotic treatment. While its exact cause remains unknown, pulmonary fibrosis is strongly linked to aging, genetic predisposition, environmental factors, and cellular senescence. Ongoing research aims to identify reliable biomarkers and develop targeted treatments to enhance patient outcomes. This randomized controlled trial will examine the effects of quercetin supplementation (500 mg/day for two 12-week cycles, with one 8-week washout periods) on telomere length, senescence-associated secretory phenotype (SASP) factors, and lung function in patients with IPF and F-ILDs. A total of 100 patients will be recruited, with half receiving quercetin (despite their standard of care therapy) and the other half receiving standard care (SOC). Primary outcomes will include changes in telomere length, SASP protein levels (IL-6, MMPs), fractional exhaled nitric oxide (FeNO), spirometry (FVC decline), and oscillometry measurements. Additionally, quality of life will be assessed using the L-IPF Questionnaire. This study aims to explore quercetin's potential to reduce fibrosis, decrease inflammation, and improve lung function in F-ILDs, offering new insights into potential novel strategies for F-ILD management.