As readers of my column, you know that I write about the journey of life and the emotions of living with cystic fibrosis (CF). This week, I want to address a topic that makes me sad and frustrated. I’ve made it my mission to shine a light on the current clinical trial inclusion criteria — specifically minimum lung function.
I’ve been excluded from almost all trials involving investigative treatments for CF, due to having lung function below the 40 percent forced expiratory volume in one second (FEV1) inclusion limit. It’s frustrating that I’m ineligible for participation in clinical trials because of this one criterion. I know that I am not alone — many adult patients with low FEV1 have a good quality of life and live with far greater levels of general health and physical fitness than our FEV1 would suggest.
I may never benefit from new medications in the future because my health is deteriorating, and I may require a lung transplant before FDA approval has been granted for these medications. After transplant, my new lungs won’t have CF, and those medicines will not be as vital to my care.
But I’m choosing not to dwell on these aspects. Instead, I will turn my frustration into action.
I wrote a column published by MedPage Today that describes this situation. In it, I suggested alternative selection criteria and methods. I hope to reach those responsible for determining clinical trial criteria, specifically the 40 percent FEV1 inclusion limit. I am deeply motivated and passionate about this, and I hope my message will reach those who need to hear the perspective of a person with cystic fibrosis.
Thank you for reading and sharing.
Ella is a writer, patient advocate, and scientist with cystic fibrosis. She was diagnosed with CF at 18 months old and is now in her late 20s. She holds a degree in biology from Virginia Commonwealth University and works part time as an environmental microbiology lab manager. Over the last few years, she’s become deeply involved in the CF community via advisory and research committees while also serving as a director for the U.S. Adult CF Association. She’s from Richmond, Virginia, but is of Hungarian descent. She loves the ocean, traveling, spending time outdoors, practicing makeup, and eating her favorite dessert, crème brûlée. Follow her travel and life experiences on Instagram @thisgirlella.