What the trial was testing
The FLORA enrolled 23 patients with pulmonary fibrosis. The study was sponsored by Lakefront Biotherapeutics NV and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). 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 taking the drug maintained lung capacity while the placebo group lost function over 12 weeks.
The Lancet. Respiratory medicine · 2018 · NCT02738801
These findings — that lung capacity held steady on the drug but dropped on placebo — were published in the The Lancet. Respiratory medicine and represent the headline result of the study.
Researchers tracked outcomes across 23 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 treatment showed promise in slowing lung scarring, but it was an early-stage study with only 23 people. The drug is not yet FDA-approved. If you have idiopathic pulmonary fibrosis, ask your doctor about open trials testing this or similar treatments, or about the two approved medications for this condition.
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
Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Lung Cancer Patients
This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT. The main questions it aims to answer are: Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales. Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.
Surrogate Markers of Response to New Therapies in Cystic Fibrosis Patients
The purpose of this study is to determine which biological marker, or association of biological markers, best predict clinical response of cystic fibrosis patients to CFTR modulators.