How a failure ended up being a win for me with COPD
Not qualifying for a clinical trial ultimately spelled good news for this columnist
Several months ago, I was selected by the pharmaceutical company Sanofi to be screened for a clinical trial called AERIFY-1. The study, which is being conducted by the global research company Care Access, aims to assess the efficacy, safety, and tolerability of the investigational therapy itepekimab in people like me, with chronic obstructive pulmonary disease (COPD). I was excited that one of the trial sites was in my rural community here in West Virginia, as most trials are clustered in urban areas.
To determine my eligibility, I had to undergo multiple interviews and tests. On July 1, I had my first interview over the phone, during which I answered yes or no to 20 questions about my medical history. I was then scheduled for a second interview, which took place in my home.
This visit consisted of a general physical examination, a balance test, a peripheral vision test, a carotid artery test, and a cognitive test. I sighed in relief when I could repeat the three items the interviewer had asked me to remember.
For the second part of the cognitive test, I had to draw a clock with the hands indicating 9:45. I’d been given this test during my annual wellness visit last year and was curious about what my response might indicate. I do know that the inability to place the hands correctly can be a sign of dementia.
My third screening took place at the trial site, where I underwent an electrocardiogram, a pulmonary function test (PFT), and a chest X-ray. Once I completed those tests, I met with the pulmonologist overseeing trial participants and candidates. I had to read and sign 22 pages of paperwork at this session.
During the PFT, I could feel a COPD exacerbation coming on, so after I got home, I began taking one of the over-the-counter medications my doctor has instructed me to take during allergy season.
A week later, I had to fast for bloodwork, and then complete a second PFT. I still wasn’t feeling well during this screening.
I was scheduled to return in a week and repeat the same regimen. Trial coordinators explained that, if accepted, I’d then begin receiving injections of either itepekimab or the placebo, which would be randomized and double-blind.
Things take a turn
The following week, I returned to the site where I repeated the bloodwork and had a third PFT. The nurse who performed the test told me I needed to see the pulmonologist for a quick physical, and then return to her to complete a walk test.
When I returned from the pulmonologist’s office, the nurse informed me that my latest PFT results disqualified me from participating in the trial. Participants must have moderate-to-severe COPD, and though this status was confirmed by my first two PFTs, the third one showed enough improvement that I no longer fell under the moderate-to-severe classification.
These results were unsurprising. Between my last two screenings, I’d visited my pulmonologist and done a PFT with him, and he was ecstatic about how much I’d improved since my last visit. He said we’d better not change my care plan, since it seemed to be working. I think part of the reason for my improved score was taking medication after my first screening at the trial site, when I felt a COPD exacerbation coming on.
I’m still on oxygen 24/7 because my lung diffusion test (DLCO) results are in the toilet. Those results mean my lungs aren’t moving oxygen to my blood efficiently. The main component of my COPD is emphysema, and my low DLCO results are consistent with that diagnosis.
I never thought I’d celebrate failure, but failing to qualify for this clinical trial is ultimately a positive for me. It reaffirms that my health is improving and that I’m knowledgeable enough about my body and health to recognize changes in my COPD symptoms.
Note: COPD News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of COPD News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to chronic obstructive pulmonary disease.
About the Author
Comments