Final Program
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WEDNESDAY • MAY 18 391<br />
L21<br />
AIRWAYS CLINICAL RESEARCH CENTERS , ALA<br />
LATE BREAKING RESULTS FOR THE ALA-ACRC<br />
LASST STUDY<br />
12:15 p.m. - 1:15 p.m. MOSCONE CENTER<br />
Room 3006/3008 (West Building, Level 3)<br />
Target Audience<br />
Physicians, clinical scientists, nurses, paraprofessionals, educators, health<br />
care providers.<br />
Objectives<br />
At the conclusion of this session, the participant will be able to:<br />
• learn new findings about new, safe, and effective approaches to asthma<br />
treatment;<br />
• gain new strategies to manage the care of asthma;<br />
• learn new findings about adherence, safety, and tolerability of LASST.<br />
The ALA Airways Clinical Research Centers’ (ACRC) purpose is to conduct clinical<br />
trials with practical importance to both adults and children with COPD and asthma.<br />
One of the trials was the LASST Study (Long-acting Beta Agonist Step Down<br />
Study). This trial verified these findings: to test the hypothesis that in patients with<br />
well-controlled asthma on combination ICS/LABA, discontinuing LABA while<br />
continuing with the same ICS dose will be inferior to continuing LABA and reducing<br />
the dose of ICS in preventing treatment failure during step-down therapy. This<br />
session will be the first presentation of the results of the LASST Study.<br />
Chairing: W.C. Bailey, MD, Birmingham, AL<br />
R.A. Wise, MD, Baltimore, MD<br />
12:15 LASST Background and Rationale<br />
K. Blake, PharmD, Jacksonville, FL<br />
12:30 LASST Study Design and Baseline Characteristics<br />
C. Bime, MD, Tucson, AZ<br />
12:45 LASST Main Results, Summary, and Conclusions<br />
L. Rogers, MD, New York, NY<br />
1:00 Discussion/Questions and Answers<br />
R.A. Wise, MD, Baltimore, MD<br />
L22<br />
NATIONAL INSTITUTE FOR<br />
OCCUPATIONAL SAFETY AND HEALTH<br />
RESPIRATORY HAZARDS OF WORKING WITH<br />
METALS: FROM MACROPHAGES TO<br />
MICROBIOMES<br />
12:15 p.m. - 1:15 p.m. MOSCONE CENTER<br />
Room 3020/3022 (West Building, Level 3)<br />
Target Audience<br />
Providers of lung health; clinicians caring for industrial workers; clinicians and<br />
researchers with interest in exposure-related lung disease.<br />
Objectives<br />
At the conclusion of this session, the participant will be able to:<br />
• learn new findings about exposure to metals (beryllium, indium) and<br />
disease;<br />
• recognize occupational causes of lung disease related to exposure to<br />
metals or metalworking fluid;<br />
• improve understanding of the potential role of the lung microbiome in<br />
occupational lung disease.<br />
This session will highlight recent research at NIOSH on unique lung diseases<br />
related to work with metals. Both well-described and novel diseases will be<br />
discussed. Findings related to clinical features and exposure-response<br />
relationships will be presented. Implications for disease prevention will be<br />
explored.<br />
Chairing: K. Cummings, MD, MPH, Morgantown, WV<br />
12:15 NIOSH Research on Beryllium Disease<br />
E. Fechter-Leggett, DVM, Morgantown, WV<br />
12:30 Understanding Indium Lung Disease<br />
R. Harvey, DVM, Morgantown, WV<br />
12:45 A Novel Lung Disease Related to Metalworking Fluid<br />
R. Nett, MD, Morgantown, WV<br />
1:00 Lung and Workplace Microbiomes in a Metalworking Fluid<br />
Environment<br />
L. Segal, MD, New York, NY<br />
L23<br />
U.S. FOOD AND DRUG ADMINISTRATION<br />
PULMONARY UPDATE FROM THE U.S. FOOD AND<br />
DRUG ADMINISTRATION<br />
12:15 p.m. - 1:15 p.m. MOSCONE CENTER<br />
Room 3016/3018 (West Building, Level 3)<br />
Target Audience<br />
Clinicians in practice, researchers, pharmaceutical industry representatives,<br />
international regulators.<br />
Objectives<br />
At the conclusion of this session, the participant will be able to:<br />
• understand how FDA-approved biomarkers can be used to enhance clinical<br />
trial drug development;<br />
• learn new therapeutic targets for asthma (general asthma population as<br />
well as specific phenotypic subsets);<br />
• integrate new treatment options regarding maintenance bronchodilator<br />
choices for management of stable asthma, and understand the role of<br />
clinical and biomarker criteria for patient selection for anti-IL-5 therapy.<br />
The most recent regulatory FDA actions including discussion of current safety<br />
and efficacy issues of products for pulmonary indications will be presented. A<br />
summary of the Agency’s biomarker qualification process exemplified by the<br />
recent qualification of fibrinogen for use in COPD clinical trials will be discussed.<br />
Recent approvals for asthma highlighting targeted therapy to specific asthma<br />
phenotypes, as well as the use of a long-acting anticholinergic as a new<br />
bronchodilator in asthma will be presented.<br />
Chairing: L.I. Gilbert-McClain, MD, Silver Spring, MD<br />
WEDNESDAY MID-DAY<br />
ATS 2016 • San Francisco