Clinical Trial Washout Periods
It is funny how mapping out a work or a travel schedule can have you contemplating life while looking at a calendar. While putting in a bunch of travel and project dates. I realized that my clinical trial will soon be over and that I will be in a washout period before I know it. I had wondered where the last 18 months had gone and was slightly nervous for what would be to come.
What is a washout period in a clinical trial?
Definition: A period of time during a clinical study when a participant is take off of a study drug or other medication in order to eliminate the effects of the treatment.1This may also refer to a withdrawal from a current treatment before an active treatment begins.2
In the asthma studies that I have participated in, there has been a washout period before, after, or both. In one particular experience, I was going to be starting treatment on a new biologic and I had to wait three months to ensure that the half-life of the previous drug I was on had elapsed and would not interfere with the current study I would be participating in. Washout periods are almost entirely approached with the safety of the patient in mind. In my experience, the time does go quite quickly. But if you have had a positive result on a previous drug, you will still be changing to something new. It is possible, that the withdrawal of the previous drug can cause unwanted symptoms. In my situation, my trial was ending and the drug had not yet received FDA approval and was still considered investigational. You may need to try an alternative drug or return to an old regimen in the interim. I was a bit crushed when I started to develop symptoms of a flare without a drug that had provided me benefit. However, it is a necessary part of the research.
Impacts of the "washout period"
If I could advocate for one thing, in particular, I would say that there needs to be more discussion about what effects can occur during a washout period. In my experience, these time periods are covered outside the scope of study consents and sometimes doctors forget what this period could be like for patients. I don’t think I have ever felt like I was in a dangerous place or that my health was compromised but not feeling great can be both physically and emotionally draining.
It is not all gloomy, it can also highlight how stable your condition has become or the lasting effects of a drug intervention. It can even give you confidence that your asthma is able to maintain a state of zen. I know that I always want to maximize the time that I feel well by doing “all the things!” and not worry about my health failing. It is possible to have this experience, even during the washout. While my experience has been positive, if a drug failed for you, you might want to be rid of it stat!
If you have any concerns about a washout period, I highly encourage you to speak with your study Principal Investigator, Respirologist or study coordinator. I can not sing the praises more about study coordinators, the ones that I have worked with are wicked smart, compassionate and truly bridge the navigation gap in the studies I have participated in.
Have you ever gotten "moon face" as a side effect of prednisone?