Clinical trials are carefully regulated research studies that hope to find better ways to prevent, diagnose or treat diseases. For COPD, many trials focus on eliminating or lessening COPD exacerbations because this is one of the biggest problems with having a chronic disease. In our previous blog, Dr. David Hill answered some of the most frequently asked questions for patients who are considering a trial. American Lung Association Spokesperson Dr. Panagis Galiatsatos spoke with us about what happens next; once you decide to and have been chosen to participate in a clinical trial.

When creating a clinical trial, the first thing researchers will want to determine is what they are hoping to improve. For this reason, disease management is a particularly hot topic for COPD researchers. Before meeting with patients, they will need to establish their expected outcomes, which must align with the needs of any patient who is participating in the trial.

What happens at the first appointment?

When you join a trial, you will want to understand what to expect. A clinical trial’s goal is to introduce something new that is an addition to or in place of your current standard of care. Before the trial begins, here are some questions to ask at your initial meeting:

  • How much will this new treatment deviate from my current method, and how will that affect my overall lifestyle?
  • If I’m being randomized, is there a chance I may get a placebo instead of the intervention?
  • If there is a placebo involved, can I get the active intervention after the study, if it proves to be effective? 
  • How much of the heavy lifting will I be expected to do: how many doctors’ visits, how many medication changes, etc.?

Before anything begins, make sure you are comfortable with these probabilities, and discuss any concerns that you might have up front. You will also need to define with the researchers where their threshold is and, if it is met, how to end your participation in the trial.

Will the researchers work with my current physician?

The research team will always need to talk with your healthcare provider, especially if they’re introducing an intervention that is going to change your medication or behavior. This could mean talking with your pulmonologist or primary care physician. Since you usually touch base with your providers more frequently than the research team, transparency between everyone allows the researchers to adjust and address any problems you may be having.

What if I feel worse during the trial? Can I leave the trial? 

Yes. If you become uncomfortable in any way, whether it be with additional symptoms or just the burden of being enrolled, you may want to withdraw from the study. Trial participants have the option to leave at any time.

How can a clinical trial boost my COPD management plan?

It depends on what that trial’s primary outcome goal is. As previously stated, most COPD trials right now are exploring how to reduce the frequency of exacerbations because they are disruptive to patients’ lives. Other, less common COPD trials may focus on improving daily breathlessness or improving some objective measures like lung function tests, but these trials are not as abundant. So, your COPD management plan may be improved by outcomes such as finding that your day-to-day breathing is improved, or you are having less frequent urgent doctor visits or hospitalizations.

Some current clinical trials are embracing biologics that are used for asthma management and applying them to COPD. I think they will help significantly reduce exacerbations, an exciting thought because up to this point, biologics have been used to treat many diseases but not yet COPD.

What steps were taken to determine if the treatment works before I was asked to join this trial?

For any clinical study to get to the level where it is recruiting patients, it has already undergone several phases. The intervention is tried first in petri dishes, then in mammals, then in select small groups before opening to real world patients. The problem is all these initial trials are done in isolated situations, but once they are open to real world factors, the outcomes for the intervention may change. For instance, how well does an inhaler work in areas with highly dense air pollution versus cleaner air? How well does that inhaler work for a patient with COPD who is constantly around kids who are sick, (like teachers or healthcare workers) versus someone who is more isolated, lives alone and doesn't go out?

The intention of picking broad, diverse groups to participate in the trial is to test the intervention in diverse environments and see which populations seem to benefit most. We use proxies such as race, ethnicity, age and gender to determine why changes may work for one group and not another. Often those signals only come to light when we have a diverse population, because social factors affect the strength of the medicine.

When will I learn the results of the trial?

Be sure to ask, because it really varies. On average, from the time of enrollment to the time of finally publishing the data for public use, it could be five to six years. This is a very different timeline from developing COVID vaccines because everyone was working on the same problem, so it was fast tracked and took about a year. But there are so many competing priorities, so the process is a bit longer with most studies.

Participants, however, may start to see changes to their symptoms, feeling better or worse, at any time. But those findings will just not be published for many years and after much more data is collected and analyzed.

Clinical trials are vital to safely make new advancements in medicine. Find out if one is right for you.

Content created in partnership with Horizon Therapeutics and Sanofi Regeneron.

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