What is the large-scale study looking to bring to clinical respiratory health understanding?
Respiratory conditions including asthma and chronic obstructive pulmonary disease (COPD) are common conditions increasing steadily in the US population. But unlike other common chronic diseases, few reliable biomarkers exist for clinicians to gauge patient risks.
In an interview with MD Magazine®, Al Rizzo, MD, chief medical officer of the American Lung Association, explained how the upcoming ALA Lung Cohort trial is looking to address the limited depth of lung disease biomarkers currently available.
MD Mag: What is the ALA Lung Cohort, and its significance in chronic lung health care?
Rizzo: A little background: all of us, when we develop, from our childhood up into adulthood, our lungs are developing. We reach a peak of normal lung function in our mid-20s. From there on out, we have a normal slow decline in our lung function until we're up in the 70s or 80s. And it's usually not enough to lead to impairment, unless we have other conditions.
But we don't know really what might be an early sign of a deterioration in the lungs that is more than the normal amount. So the Lung Cohort study is going to look at individuals in the 25-35 year age group who are essentially healthy. They're going to include some people with mild asthma.
And they're going to do a one-time exam at the start, looking at CT screening, pulmonary function tests, some blood work, and more importantly, a series of questionnaires that look at individuals’ lifestyle choices: environmental exposures, occupation, family history, things of that nature. And then, follow them over the course of at least 5-6 years with repeat questionnaires along the way, and potentially even a longer time frame, to see what happens in individuals who develop lung disease. Was there an early marker in the age 27-30, where there was something changing that could have at some point been identified as a risk factor for developing lung disease?
An analogous situation would be cardiac studies that were done years ago showing that cholesterol is a marker for having lung disease. You have a high cholesterol, you treat it with cholesterol-lowering drugs, you decrease your risk of a cardiac event. If we can find the same type of marker in lung disease, we might be able to intervene when somebody is not having lung disease, and not have to wait until they are lost a lot of lung function and have COPD that now requires medication that really can't cure them but only can help their symptoms.
So the Cohort Study we're hoping for is going to take a while—5, 10, maybe in 15 or 20 years—to get all the data out of what the changes may occur in our lungs over the course of that time. But it's never been done before, and it's well overdue in order to come up with a marker that might tell us when the lungs are deteriorating faster than they should be.
MD Mag: How can people join?
Rizzo: Well the study right now is in the process of finalizing its protocol, and really won't be enrolling until January of 2021. There'll be some of the sites that will roll out little earlier than that. And what I mean by sites is the American Lung Association has a network called our airways clinical research centers. There’s about 15-20 sites across the country that do clinical trials in asthma, COPD, other airway disease.
But this cohort, as I said, is going to be relatively healthy. But at each of those sites, people will be able to enroll and become among those 4000 Millennials that we hopefully will enroll over that period of time, and the American Lung Association will be sending out information about how individuals will be able to be recruited into those studies.
The important thing about it is that it’s not only the initial recruitment, but we want to retain hold of these individuals over the course of years. We're going to want to check back with them in a year or 2—what's happening in their lives, what's been the change in their lifestyle. Without retaining their input, we're not going to be able to really see what happens over the course of time. So all those things, we're going to work hard to come up with answers, work together with our networks, and the American Lung Association.