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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

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