What is the Current Clinical Development for Respiratory Conditions?

COVID-19 is a disease that heavily affects the respiratory systems of those that contract the disease. Inspired by Respiratory Care Week, we must pay particular attention to highlighting the efforts to promote further research and help create more awareness about the numerous respiratory diseases that affect so many people. The week is devoted to panels, events, and public awareness efforts that show people what they can do to take care of their lungs, breathe well, and enjoy life longer.

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We spoke with our experts about advancements in treatments for patients suffering from respiratory illnesses and their impact during the COVID-19 pandemic.

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Samantha Mineroff
Samantha Mineroff
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We spoke with our experts about advancements in treatments for patients suffering from respiratory illnesses. Marcelo Vaz, MD, PhD, FCCP, Director of Medical Affairs - Therapeutic Expertise and Sushant Sehrawat, MD, Medical Director - Pulmonology and Intensive Care share their insights on what the future holds for these treatments.

This is the first of two blogs we have devoted to Respiratory Care Week. Read the second one here.

What is your experience and expertise with regards to respiratory care?

SS: I'm a respiratory physician by qualification. I did my post-graduation and specialization in Respiratory medicine in India. Following that, I was a respiratory physician for five years, working in a clinic and taking care of patients in the outpatient department and in the intensive care unit. I have five years of clinical experience in pulmonology and intensive care followed by 13 years of experience as a Medical Monitor in pharma and CRO in global clinical development in various respiratory indications, along with other therapeutic areas. I’ve helped clients execute their protocols on the ground, as well as writing the protocols, suggesting various endpoints, suggesting protocol designs, visits, and schedules for protocol, and conducted other medical monitoring and safety monitoring activities.

MV: I am a board-certified pulmonologist with more than 23 years of patient care experience in the hospital’s outpatient and intensive care department. I've been teaching pulmonology at a university for 20 years as well as 14 years in the pharmaceutical industry/CROs. In Brazil, I coordinated post-graduation in pulmonology in two universities and received my Doctorate in Pulmonology. My focus has mostly been in asthma, Chronic Obstructive Pulmonary Disease (COPD), Pleural Disease, Oncology (lung), Interstitial Lung Disease (ILD), Cardiovascular, Metabolism (Diabetes Melitus included), Gastrointestinal, Urinary System, women’s health, and Rheumatology.

I joined PRA this year. In Pharma/CRO, I worked crafting study protocol and drug development plans and providing support on medical monitoring and safety monitoring. I assist from virtual Pharma to big pharma companies from Phase I to Phase IV, including device development, app development, biologics, and generic drugs. I’ve also worked on all kinds of therapies that we have available in the respiratory area.

What advancements have been made to improve respiratory care?

MV: There have been many advancements in the last 20 years. It started targeting lung delivery drugs with inhalatory medications that ensure rapid and direct delivery to the patient airway and lungs and can be provided through a range of devices, like the pressurized inhalers you have probably seen, Dry powder inhalers (single and multidose) and nebulizers. Additionally, recent research has brought to the forefront a new set of therapies that target specific disease phenotypes. We used to state that asthma is a single disease—we now understand that asthma has several disease different phenotypes and different inflammatory profiles. Every single one of them may have a specific kind of medication or delivery mechanism that is more effective for that condition. These findings allow us to improve our care for the patient.

Most medications are being directed today on the inhalatory route because it's much safer, it's easier, and leads to fewer adverse reactions. It was a true improvement in therapy because it improved control of many diseases in the respiratory area such as COPD and asthma. For future we may expect new medications using intracellular drug delivery systems targeting more selective effects and lesser adverse reaction and also potential advances in lung regeneration through genetic and cell therapy.

In the inpatient setting, there have been many advances with regards to respiratory isolation and personal protective equipment, as we can clearly see being applied during the COVID pandemic. There’s been an advancement in respiratory support with the development of new generations of ventilators, both invasive and noninvasive, protective modes of ventilations, and extracorporeal membrane oxygenation equipment. These tools are making significant differences in patient care and saving lives. Most of these mentioned are in-hospital techniques that are being widely used in this pandemic.

Despite all recent advances some patients can be resistant to therapy, such as adolescents as research has shown, because of the perceived social stigma surrounding device use of being “weak” or “frail.” There is a general sense, stronger among teenagers, but not limited to them, that human beings must be strong and minimize/overcome any challenge in their pathways in order to be cool or popular. Therefore, any sign of a disease may be understood as a sign of weakness. This may be magnified by the fact several respiratory diseases may impact exercise performance (mainly if not adequately treated), which is an important component on group popularity and becoming a target of bullying. As a result, patients may start closing themselves off and be discriminated in their social/school environment. Communication has improved considerably in the last few years, which means that the patient has a better understanding of the disease, and also allows better interactions between the patient and the medical team. This information sharing improves the patient’s understanding of their condition and treatment, which can lead to improved medication compliance. Technology plays a part in this, too. New devices arriving in the market can be used that control the intake of medication. There are apps that give the patient reminders to take medication and may provide positive and motivational feedback. These technologies may help out-patients be more effective in managing their own disease and medications.

SS: There is also an infective component to respiratory illnesses. Certain infections like pneumonias and bronchitis are also respiratory illnesses. There are new antibiotics and anti-microbials that were developed in the last 20 years, which are effective treatments for these illnesses that we didn’t have before.

Certain respiratory illnesses are not often seen in the western world. For example, tuberculosis is widely prevalent in lower income countries. Morbidity and mortality surround this illness, but because the prevalence in higher income countries is lower, they’re often neglected and not much investment goes into drug development. However, over the last 20 years we have seen more and more new tuberculosis treatments being made available.

What are you most excited about regarding the future of respiratory care in terms of therapeutics and preventative medicines?

MV: Respiratory medicine has huge potential for innovation and development. Many targeted respiratory medicines are expected to be developed in the near future, outpacing oncology medicines in some instances. Understanding the biology behind disease phenotypes and specific subgroups of patients who are more sensitive to some specific therapies may allow further development of targeted treatments focusing specific disease pathways (particularly for a subgroup of patients). That said, it takes a lot of time to conduct studies to ensure the drug is safe and effective. Authorization for getting a drug to market typically takes around 8-10 years or more. Whilst we don’t expect it to take that long with any COVID-19-related therapeutic, the timeline remains for those treatments not on the COVID-19 track.

The addition of new devices integrated with apps and self-monitoring tools in patient care allows the patient to be more compliant and connected with their own health and treatment. This is one of the advances that excites me the most.

We’re also seeing development in medications that currently exist. For example, treatments previously administered by intravenous or subcutaneous methods are being developed to be delivered to a patient by inhalation or orally. These are less invasive routes of medication administration, reducing the burden the patient feels during treatment. At the same time, it provides a better control of the disease with less adverse reactions.

SS: What I find most exciting is the rise of personalized medicine. If we can develop different medications that are more targeted towards a specific phenotype for diseases such as COPD or idiopathic pulmonary fibrosis (IPF), I think that's so exciting.

PRA has supported 80+ clinical studies across multiple respiratory indications, targeting 15,600+ patients at 3700+ sites globally. This includes a study that is investigating the efficacy and safety of a combination therapy to reduce hyper-inflammation and respiratory distress in patients with COVID-19.

Learn more about our respiratory expertise.

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