Several noon sessions will provide attendees with the latest developments in ongoing clinical trials research and clinical practice guidelines from the Food and Drug Administration (FDA), National Institute of Allergy and Infectious Disease (NIAID) and the U.S. Critical Illness and Injury Trials Group (USCIIT).
L10 “Pulmonary Update from the U.S. Food and Drug Administration,” which will take place from noon to 1 p.m. on Monday, May 16, will offer pertinent regulatory and scientific information about therapeutic products for use in pulmonary practice and pulmonary drug development, according to session chair Lydia I. Gilbert-McClain, MD.
Lydia I. Gilbert-McClain, MD
The session will begin by covering safety concerns regarding the use of long-acting bronchodilator products (LABAs) for the management of asthma in the wake of recently revised labeling that contraindicates their use without the concomitant use of a long-term asthma control medication such as an inhaled corticosteroid (ICS).
“Physicians taking care of asthma patients must carefully weigh the risks of LABAs use versus the benefits of using LABAs to help control asthma,” said Dr. Gilbert McClain, who is deputy director of the Division of Pulmonary and Allergy, and Rheumatology Products at the FDA. “However, the current available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control medication are effective in mitigating the increased risk of asthma-related death from LABAs.”
Attendees will learn about the design of a long-term safety study that the FDA is requiring of developers of LABA products to determine the safety of a LABA added to ICS compared to ICS alone.
The session will then cover the diagnostic agents for bronchial hyperresponsiveness in patients with an unclear diagnosis of asthma. “With the approval of ARIDOL (Mannitol dry powder) in October, another diagnostic option is available to physicians treating patients requiring this type of assessment,” said Dr. Gilbert-McClain. “Attendees will understand the differences between the ARIDOL bronchial challenge test and the methacholine challenge test and gain insight into the overall approach for the development of diagnostic agents for bronchial challenges.”
The final part of the session will discuss the potential role of phosphodiesterase inhibitors in the management of COPD. “Attendees will appreciate that the drug development for COPD can be targeted to a subset of the COPD population,” Dr. Gilbert-McClain said. “Physicians taking care of COPD patients have limited therapeutic options (bronchodilators [short-and long acting beta agonists, and short- and long-acting anti-muscarinics]), and fixed-dose combination products containing LABA and ICS. Given the heterogeneity of the COPD population, drug developers and physicians must recognize the possible scenario of COPD therapeutics that is targeted to a subset of the COPD population.”
New Food Allergy Guidelines
Food allergies are the focus of L18 “New U.S. Guidelines for the Diagnosis and Management of Food Allergy,” which will take place from noon to 1 p.m. on Wednesday, May 18.
Matthew Fenton, PhD
ATS members should take note of the guidelines as asthma is frequently associated with food allergy, said session chair Matthew Fenton, PhD. “Moreover, the risk of severe food allergy reactions is highest in patients with asthma,” said Dr. Fenton, who is chief of the Asthma, Allergy and Inflammation Branch at the NIAID. “Physicians need to be aware of the signs and symptoms of food allergy, how to accurately diagnose this disease and differentiate it from food intolerance, how to treat severe allergic reactions, and how to educate patients and their families on the avoidance of problem foods.”
The recently published NIAID-sponsored guidelines are the first evidence-based clinical practice guidelines for food allergy developed for health care professionals from specialists to primary care physicians. The guidelines provide a consensus definition for food allergy and food allergens, as well as “best practice” recommendations for the diagnosis and management of this disease, said Dr. Fenton.
The full guidelines, a summary report and lay language materials for patients are free and readily available on the NIAID Web site.
The session will cover how the NIAID developed the guidelines with the input of 34 professional societies, advocacy groups, NIH institutes and federal agencies. Next, the session will discuss the limitations of using blood tests and skin prick tests alone to make a diagnosis of food allergy. “These tests are indicators of allergic sensitization and not clinical disease,” Dr. Fenton said. The guidelines also provide a list of tests that are not recommended for use in diagnosing food allergy, in spite of their product claims.
Lastly, the session will provide examples of how the best practices described in the guidelines can be applied in routine clinical practice by pulmonary and critical care physicians and other health care professionals.
Critical Illness and Injury Trials
Participants of L9 “U.S. Critical Illness and Injury Trials (USCIIT) Group: Clinical Trials Update,” which will take place from noon to 1 p.m. on Monday, May 16, will learn the latest news from the USCITT group. The group, which first called for proposals in 2008, was established to promote clinical research and the application of new data to improve outcomes for critical ill or injured patients of all ages and stages of care (pre-hospital to recovery). The group formed a nationwide network of experts to review published data, establish national priorities, vet hypotheses, write clinical protocols and generate pilot data.
Among the groups aims are to provide a venue for discussing education and training in the science of clinical trial design, conduct, analysis and reporting for critically ill or injured patients, and to insure patient protection and privacy by addressing the ethical, legal and social implications of research in the specialized circumstance of critical illness or injury.
The session will cover a variety of topics of interest to ATS members. It will begin with a discussion of lung injury prevention studies, followed by a presentation on benchmarking tracheostomy practice for acute respiratory failure. The session will close with a presentation of critical care informatics and a panel discussion.
The session will be chaired by USCITT Group Director J. Perren Cobb, MD, who also directs the Critical Care Center and serves as vice-chair for critical care at Massachusetts General Hospital in Boston.