RT discussed market trends and the latest developments in aerosol delivery products with Conor Duffy, PhD, senior scientist for Aerogen Ltd; Dave Henry, RRT, respiratory clinical specialist for DeVilbiss Healthcare; and Shariq Khan, clinical studies manager, medical division, Omron Healthcare Inc.

RT: What are the latest trends/new developments in aerosol delivery products?

Conor Duffy: There is an increase in the number of aerosol devices and drug-device combinations in development for the delivery of medication to patients with the sickest of lungs in the home, acute, and critical care environment. From bronchodilators to antibiotics and prostanoids, newer technology is allowing highly efficient targeted delivery to patients’ lungs. Treatments for pulmonary hypertension, ventilator associated pneumonia, and even infant respiratory distress syndrome have been the targets of recent development efforts. Drugs originally approved for delivery by other routes are being reformulated and tested for safe and targeted delivery to the lungs. New drug entities are also in development, although that engenders longer development times and greater risk for the sponsors.

Dave Henry: Many manufacturers have moved to creating smaller, more economical aerosol compressors. Often, quality is sacrificed for cost so the challenge continues to be to meet these market demands while maintaining product quality and medical efficacy. New developments have largely flattened out due to the primary focus on reducing costs as much as possible. With that said, compressor nebulizers continue to be the mainstay for aerosol delivery in the home care market.

Shariq Khan: The aerosol delivery market offers a wide variety of products to consumers and health care professionals—ranging from the traditional large compressor-based nebulizers to metered dose inhalers (MDIs) and dry powder inhalers (DPIs). You can also find some sophisticated jet or ultrasonic nebulizers; but if you are a health care professional who demands innovation, optimal performance, small size, and portability, consider a vibrating mesh or plate aerosol device that produces a liquid aerosol. These devices offer the most advanced technology in the nebulizer industry.

Conor Duffy, PhD • Aerogen Ltd
Dave Henry, RRT • DeVilbiss Healthcare
Shariq Khan • Omron Healthcare Inc.

RT: Tell us about your company’s most recent aerosol delivery products and why they are innovative.

Duffy: The Aeroneb Solo provides all of the advantages of the original Aeroneb Pro, being a single-patient-use, multidose disposable nebulizer, designed to use for up to 1 month. This represents an order of magnitude reduction in cost to the user and a major breakthrough in vibrating mesh technology.

The Solo has been designed to work with both standard unit doses as well as an innovative liquid feed from bag or pump to allow long-term continuous drug administration. Because the vibrating mesh, aerosol generators can allow single drops to be nebulized with minimal waste, the aerosol output can be regulated by the rate at which individual drops of drug are pumped into the nebulizer. The Aeroneb Solo, with its active vibrating mesh technology, allows accuracy and control of aerosol output. The output can be accurately adjusted with a change of input rate of drug entering the nebulizer, up or down, to meet the needs of the patient. Previously, this level of accuracy and control has been available only with intravenous drug administration. The Aeroneb Solo sets a new standard for precision aerosol generation, beckoning the era of the pulmonary infusion pump.

Henry: The DeVilbiss PulmoNeb® LT Compressor Nebulizer System is our latest generation compressor. We gave it a smaller footprint, made it lighter, and reduced the number of parts while maintaining all of the performance and quality characteristics that the market has come to expect from a DeVilbiss product. Specifically designed for assembly in a “lean” manufacturing environment, [it enables us] to respond quickly to unanticipated increases in customer demand for compressors such as those caused by a longer or more severe flu season or an outbreak such as the H1N1 virus.

Khan: Omron’s most recent product in the respiratory area is our portable nebulizer, the Micro Air with vibrating mesh technology. Micro Air is the world’s smallest nebulizer utilizing vibrating mesh technology to efficiently deliver solution medications for patients suffering from asthma, COPD, or other respiratory conditions. Patients appreciate the small product size and carrying case because that allows them to easily transport the Micro Air wherever life takes them. The Micro Air’s powerful delivery of the medication is comparable to tabletop compressor nebulizer systems while providing effective relief and control of the disease.

The Micro Air is a convenient alternative to MDIs that delivers most solution medications sold in the market. It weighs only 6 ounces with 2 AA batteries that can last up to 40 treatments. Its tubeless and cordless operation provides portability and ease of use while it delivers medication to the last drop to maximize the benefit of treatment. The Micro Air with vibrating mesh technology can also deliver undiluted medications to shorten treatment time.

RT: Tell us about upcoming trends/products that your company is working on that will be introduced in the future.

Duffy: Aerogen’s research and development team is working on a full pipeline of new aerosol delivery devices, all of which are being designed to fill unmet needs in the respiratory therapist’s arsenal for effectively dealing with respiratory disorders. Of particular note are our products in development designed to address aerosol delivery in noninvasive ventilator modalities in both the acute and subacute setting. We are also working on higher efficiency nebulizers to enable faster delivery times and therefore increase ease of use and patient compliance.

Henry: The overarching development philosophy at DeVilbiss is to create products that are increasingly simple and convenient for patients to use while at the same time delivering superior clinical outcomes. The PulmoNeb LT System and the DeVilbiss Traveler® Portable Compressor Nebulizer System continue to push the size and portability envelopes. We have implemented stringent development and lean manufacturing processes to increase product consistency and reliability and ensure that our compressors play their part in allowing patients to maintain therapy compliance. Last, but certainly not least, is our continued focus on clinical outcomes. We recently introduced a new line of nebulizers, the VixOne™ disposable and reusable nebulizers, that, when paired with our compressors, can significantly reduce treatment times and increase medication deposition.

Khan: Omron plans to continue with the Micro Air, moving forward as it offers the latest in nebulizer engineering advancements anywhere while maintaining the lifestyle conveniences.

RT: An August article in Mayo Clinic Proceedings suggests that oral medications might be better than inhaled medications in treating asthma. Can you comment on this?

Duffy: I am assuming this is the Tan et al paper from Mayo Clin Proc. 2009;84(8):675-684. From my reading of the paper and associated editorial, the critical finding is that compliance levels among those patients prescribed inhaled steroids are described as “dismal and discouraging.” Tan et al support the existing recommendation to use inhaled corticosteroids as the preferred initial treatment but with the proviso that clinicians act to improve adherence. The conclusion of the paper is that “care management interventions should focus on improving adherence to inhaled corticosteroid therapy so that optimal clinical and economic outcomes can be achieved.” In summary, both oral and inhaled treatments of asthma are efficacious, with clinical studies showing that inhaled corticosteroids are more efficacious than oral therapies.

Henry: There are currently quite a few well-respected standards that note inhaled medications as the preferred method in treating asthma. The Global Initiative for Obstructive Lung Disease (GOLD) standards suggest that inhaled delivery is preferred. The Global Initiative for Asthma (GINA) standards refer to a “major advantage” to the aerosol route as preferred. So unless there are multiple references to another route of information, aerosol should remain the preferred route of delivery.

Khan: The National Heart, Lung and Blood Institute’s National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR 3) recommends a step by step approach in managing asthma. However, at present, the appropriate pharmacotherapy for managing asthma remains debatable and uncertain.

The study you are referring to, “Impact of Asthma Controller Medications on Clinical, Economic, and Patient-Reported Outcomes,” is a great study that highlighted many factors such as the association between therapeutic classes of asthma controller medications and patient-reported asthma control problems, quality of life, work productivity and activity impairment, as well as clinical and economic end points that have not been studied before or discussed at this level. The results of this study will definitely have an impact on how physicians will treat and manage asthma for their patients going forward.

Numerous trials have evaluated the effectiveness of asthma medications and how these medications have improved the clinical outcome; unfortunately, the results of these clinical trials lack consistency. The point here is that, when physicians are devising a treatment plan for their patients, they must consider all options that are available to them—oral versus inhaled corticosteroid (ICS) treatment, monotherapy with ICS versus a combination of ICS and long-acting beta-agonists (LABAs), or ICS with a leukotriene modifier (LM) etc. One treatment plan does not work for all patients. Some may respond better to oral meds alone, while some respond better to an inhaled treatment, and some others might respond best to a combination therapy. We are not at a point where we can safely say that one drug will work for all, although I wish this was the case.

RT: What do these findings mean for the aerosol delivery market?

Duffy: The critical finding is that providing patients with devices that minimize the time and complexity associated with taking their medications is vital to achieving good patient outcomes. The focus needs to be on the patient interface and interactions so as to maximize compliance, thus ensuring the efficacy of clinical trial findings when translated to real-world conditions.

Henry: As mentioned above, clinical standards still prefer the inhalation route, and until there is a large body of data to the contrary, aerosol will be preferred.

Khan: I doubt whether the findings of this study will have a major impact on the aerosol delivery market. However, it will further remind physicians and therapists of the importance of adherence to the treatment plan, whether it involves oral or inhaled therapy. They will have to discuss this with their patients at length and further educate them during clinic visits.

RT: Do you have any advice for RTs on how their patients can gain the most benefit from their aerosol products?

Duffy: Ensure that patients are adequately informed on how to use and maintain their devices properly. Encourage them to be as compliant as possible with their therapeutic regimes. Provide demonstrations and return demonstrations with both initial instruction and periodically thereafter. An effective method is to ask patients to bring their aerosol device to clinic visits and show clinicians how they commonly use the device.

Henry: My father had asthmatic bronchitis for over 20 years. I felt it was important to discuss new drug therapies as well as continually reinforce proper techniques for the treatment of his disease. This educational role is a critical function of a respiratory therapist. Most patients with respiratory illnesses can lead healthy and active lives if they follow their prescribed regime. Reinforcing therapy compliance in any way possible is very important.

Khan: In order for any patient to get the most benefit out of their medical treatment, they need to adhere to a therapy or a treatment plan that they have discussed and agreed to with their treating physicians or therapists. When you have adherence, you will have increased compliance by the patients, and this combination always produces good results.

RT: What is the next “big thing” in aerosol delivery?

Duffy: The development of devices optimized for aerosol delivery in the noninvasive space will be a major factor in the continued expansion of Aerogen as a company.

The approval and release of more medications specifically developed as drug-device combinations will further demonstrate the potential for aerosol delivery. For example, Aerogen has been working with the World Health Organization (WHO) to develop a nebulizer system for the administration of inhaled measles vaccine. If the pivotal trial in India is successful, the WHO intends to license the inhaled system as a drug-device combination with the live virus measles vaccine from the Serum Institute of India. This could eliminate the need for needles for 200 million measles vaccinations each year. With more vaccine development programs in the works, inhaled delivery of vaccine offers huge potential in the near future.

Henry: Some technologies, other than compressor nebulizers, that are smaller and quieter have actually been around for awhile, but issues such as cost and reliability have prevented them from overtaking compressor nebulizers in the industry. Until these other technologies address the cost point and, as important, the reliability issue, compressor nebulizers will continue to be the choice in respiratory home care.

Khan: I would suspect that the aerosol delivery systems will remain more or less the same with an exception of design changes to make them more portable and convenient for patients. However, their application will become widespread and go beyond the typical use for asthma and COPD. We can expect to see an increase in the use of inhaled therapies in the not so distant future in hospitals’ intensive care units to administer anti-inflammatories, antibiotics, and vasodilators to treat pulmonary hypertension, to name a few. We can also expect the drug industry to increase the development of formulations to make it possible to deliver the medications effectively with precision and consistency without wasting valuable and expensive drugs.

Katie Griffith is associate editor for RT. For further information, contact [email protected].