Challenges and Necessities in Respiratory Drug Development

As medical science progresses, our ability to control disease typically improves. Cancer mortality rates have steadily declined over the past 25 years. Not many people in the developed world die from the common flu anymore. Numerous diseases have been eradicated altogether, thanks to vaccines and improved treatment.

In this regard, respiratory disease is something of an anomaly. In just a few years, incidence of diseases in this class have shot up to half a billion cases around the world. As if that weren’t troubling enough, these diseases are also becoming more dangerous: in the last forty years, their mortality rate has doubled. Researchers point to several factors as explanations for this trend. In the United States, for example, declining birth rates have created an aging population that is therefore more susceptible to respiratory illness. And while birth rates have declined, exposure to risk factors such as air pollution have gone up.1

The increasing market for treatments for respiratory diseases, coupled with their increasing danger, may lead one to conclude that there must be a frenzy of clinical research targeting these diseases. At least in Phase I, however, this is not exactly the case. A recent search on for Phase I clinical trials for some of the most common respiratory diseases yielded suprisingly few results. There were only 88 active or recruiting Phase I studies for asthma treatments, and 39 for Chronic Obstructive Pulmonary Disease (COPD). For bronchitis, there were just 10 studies. This is not the case with other major disease classes: a similar search for common non-respiratory diseases such as Diabetes and Alzheimer’s yielded far more results.

Grappling with early-phase respiratory drug trials

So what’s behind this disparity between the prevalence and danger of respiratory illness and the lack of Phase I trials for respiratory drugs? One thing to be understood when grappling with this question is that early-phase clinical trials for respiratory drugs are no picnic. They’re characteristically esoteric, unique in the type of equipment and sites where they must be conducted and the specific realm of medical and scientific knowledge they require.1 Another challenge these trials face is that, despite their strict requirements, the current mainstream methods for conducting them are prone to inaccuracies.

All of this has motivated researchers to pursue alternative approaches to early-phase trials for respiratory diseases. One of these alternatives is to conduct challenges tests, in which participants inhale a drug solution and researchers use spirometry to determine the degree to which the airways narrow as a result. A significant benefit of this approach is its ability to maximize patient eligibility; both healthy volunteers and mildly sick patients can participate in these tests, reflecting relatively broad eligibility criteria. Other approaches include organ modeling, which is relatively comfortable for patients, and local bronchial pharmacokinetics, which is unfortunately quite invasive. If there’s any relief from the headaches often posed by early-phase respiratory trials, it’s that all of these approaches are particularly well-suited to Phases I and II, which is where many of those headaches occur.1

Of course, it would be naive to think of these approaches as a panacea. While they can be helpful, they pose challenges of their own. For this reason, researchers conducting early-phase respiratory trials may benefit from seeking out additional simplifying tools, such as EDC. And now that EDC is well on its way to becoming the norm in clinical research, some EDC vendors have developed specializations that target certain research areas. For early-phase respiratory trials, helpful specializations may include a focus on Phase I, or features that counteract the complexity of these trials, such as an absence of required programming – these are qualities that have helped Medrio establish a strong base of customers with specific needs. When a class of diseases is growing in both prevalence and danger, any tool that greases the wheels of clinical research should be welcome.

1 Lins, Robert; Pharmacology Models – Early Phase Pharmacodynamic Models for Respiratory Drug Candidates; Applied Clinical Trials; 7 July 2016

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