Michael P. Pietila, MD Pulmonary, Critical Care and Internal Medicine Yankton Medical Clinic, P.C. Assistant Professor S

1. Asthma Control: Guideline BasedAmerican Thoracic Society (ATS), National Asthma Education and Prevention Program (NAEPP), and Global Initiative for Asthma (GINA) Michael P. Pietila, MD Pulmonary, Critical Care and Internal Medicine Yankton Medical Clinic, P.C. Assistant Professor Sanford School of Medicine at USD

2. Professional Relationships • I am a contracted speaker for: • Merck Pharmaceuticals • Dey Pharma L.P. Bureau of COPD Research and Education to Advance Therapeutic Excellence (BREATHE) • I will not be speaking specifically about any of these companies products today.

3. Defining and Recognizing Asthma Netter’s Anatomy

4. Asthma Epidemiology • Estimated > 23 million Americans • Prevalence 5-25% of population • Increasing prevalence and severity • USA and worldwide • Socioeconomics > genetics • $14 Billion direct annual costs in USA

5. Epidemiology • More common in males (equal after age 20). • Atopy – Skin test reactivity, elevated IgE levels, blood eosinophilia. • Indoor allergens – dust mites, animal dander. • Environmental pollution, occupational exposure. • Respiratory infections. • TOBACCO SMOKE.

6. Increasing Asthma Mortality • 500,000 hospitalizations per year in U.S. • 5-6,000 deaths per year • 1978 - beginning of increasing mortality • Role of poverty (vs. race) • Access to health care, medications, education • Greater environmental exposure • Importance of identifying persons with high risk of death

7. Definition of Asthma • Obstructive lung disease with characteristics of: • Airway obstruction;reversible in most patients • Chronic airwayinflammation (eosinophils) • Increased airwayresponsiveness • Onset of symptoms can occur at any age NAEP - Guidelines for the Diagnosis and Management of Asthma 1991

8. Guidelines for the Diagnosis and Management of Asthma Key Messages • Asthma is an inflammatory disease • Environmental factors are important • Objective measures are needed • Health education is crucial • Emphasis on recognition and avoidance of triggers Buist & Vollmer. NEJM 331:1584-5;1996 Asthma Guidelines 2007

9. Asthma Guidelines 2007 • Components of severity: • Symptoms and objective testing. • FEV1 and FEV1/FVC measurement. • Need for short-acting beta-agonist (SABA). • Nighttime awakenings. • Interference with normal activity.

10. Diagnosing Asthma • Symptoms and Medical History • Wheezing, cough, difficult breathing and chest tightness • Symptoms worse at night/on awakening • Seasonal pattern • Eczema, hay fever, family history • Triggers – animal fur, chemicals, temperature change, dust mites, drugs, exercise, pollen, URI, smoke • Symptoms respond to anti-asthma therapy • Colds “go to the chest” or last > 10 days. Pocket Guide for Asthma Management and Prevention 2011

11. Asthma Phenotypes • Intermittent/Persistent • Mild/Moderate/Severe • Adult onset wheezing • Primary asthma and secondary causes • Tends to me more severe • Occupational asthma • Neutrophilic inflammation

12. Diagnostic Tests • No single test can secure a diagnosis of asthma • Spirometry is the most helpful, preferred method for establishing diagnosis. • Increase in FEV1 of > 12% and 200 ml after inhaled bronchodilator. • Many asthma patients are negative and repeat testing is advised.

13. Diagnostic Testing • Peak expiratory flow (PEF) – aid in diagnosis and management. • Compare to patient's previous best effort • 60 L/min improvement after BD or diurnal variation in PEF of more than 20% • Bronchoprovaction testing. • Methacholine, histamine or inhaled mannitol • Skin testing or specific IgE testing for allergens.

14. Diagnostic Challenges • Cough variant asthma • Chronic cough, often at night • Exercise induced bronchospasm • Exercise challenge • Asthma in the elderly • COPD vs asthma • Occupational asthma • Must correlate symptoms with occupation

15. Goals of Therapy • Avoid troublesome symptoms night and day • Use little or no reliever meds • Have productive and physically active life • Have (near) normal lung function • Avoid serious attacks

16. Initiating Therapy • Determine level of severity. • Consider interval since last exacerbation. • Fluctuations in severity and frequency may occur. • Risk assessment: • Exacerbations requiring oral corticosteroids: • 0-1 per year in intermittent (low risk) patient. • > or equal to 2 per year in persistent (higher risk) patient. • Keep in mind the patients baseline FEV1. • Initiate treatment in a stepwise fashion. • Reevaluate level of control in 2-6 weeks.

19. Asthma Care • Patient/doctor relationship • Avoid triggers, understand and take meds, recognize symptoms and seek advice in timely fashion • Identify and reduce exposure to risk • Smoke, drugs, dust, fur, pollens, mold • Assess, treat and monitor • Stepwise approach, Ongoing monitoring q 3 monthly when stable, within 2 weeks after exacerbation. • Manage exacerbations

20. Stepwise Approach • If disease is poorly controlled • First evaluate for adherence to treatments and avoidance of triggers • Consider a step up treatments • If disease is well controlled • Step down treatments • Medications must be adjusted based on response to treatment and control of underlying disease, not on a fixed timetable. • If a medicine is not effective after 3 months, it should be stopped

21. Inhaler Technique

24. Moderate to Severe Persistent Asthma • Daytime symptoms daily and nighttime symptoms at least weekly. • Using their rescue inhaler at least once daily. • FEV1 < 80% of predicted. • FEV1/FVC ratio reduced by 5% from baseline.

25. Moderate to Severe Persistent Asthma • Moderate to High dose Inhaled Corticosteroids (ICS) are the cornerstone of treatment. • Higher potency preparations require fewer puffs and encourage compliance • Under dosing of ICS will result in poorer control

26. Managing Disease • Add in a Long Acting Beta Agonist (LABA) • Most pts in the severe category require at least 2 controller agents • Should NEVER be used as monotherapy • Leukotriene antagonists are also an option: • Limited evidence in literature • Montelukast, Zafirlukast, Zilueton • Theophylline • Limited role, controller agent only, not as efficacious as LABA’s • If symptoms are severe add oral corticosteroids. • 5-7 days if normal FEV1, 14-21 days if reduced FEV1 • Consider treatment with IgE antibody.

27. Oral Glucocorticoids • Most potent and effective controller agent. • Reserve for severe disease and those with reduced FEV1, use lowest dose possible • Should see an improvement in FEV1 of 15% after 2-3 weeks • If requiring oral GC’s every 2-3 months consider daily low dose (5-10 mg)

28. Follow-up • 4 to 8 week intervals. • Use a questionnaire to evaluate control • Asthma Control Test (ACT) • Consider spirometry if worsening symptoms or a step down in care

30. http://www.asthma.com/resources/asthma-control-test.html

31. Xolair: What is That? • Xolair (Omalizumab): Is an recombinant monoclonal anti-IgE antibody designed to treat moderate to severe allergy associated asthma. • Must demonstrate sensitization to an allergen. • Inadequate control with inhaled steroids.

32. Asthma Guidelines 2007 • Xolair therapy: • Reduce the need for systemic and inhaled glucocorticoids. • Reduce the number of exacerbations, especially severe exacerbations. • No effect on FEV1 values. • Given via SubQ route q 2 to 4 weeks. • 850 patients radomized • 25% reduction in rate of exacerbation • Overall response rate 30-50% • 12 week trial should be offered Hanania, et al;Ann Intern Med 2011;154:573

33. Co-Morbid Illness • Allergic rhinitis – treat with nasal GC’s if surgical disease refer to ENT • GERD – treat with PPI if patient is symptomatic from GERD • Vocal cord dysfunction (VCD)- referral to qualified speech therapist • OSA – study in sleep lab and treat as indicated

34. Pregnancy Variable, safe Obesity Weight loss helps Surgery PFT’s, if < 80% FEV1 steroids help Chronic sinus/rhinitis Treating these will improve asthma Occupational URI’s GER More common in asthma but treatment doesn’t reduce morbidity ASA induced 28% Anaphylaxis Special Considerations

35. Summary • Accurate and complete history and physical is crucial. • Objective testing – spirometry, methacholine challenge, peak flows, serum studies. • Classify the patient. • Step care. • Reevaluation/follow-up.

36. Summary • Written action plan • Proper inhaler technique • Trigger avoidance • Inhaled GC’s are cornerstone of therapy • LABA’s should be added next • LTA’s or theophylline follow • Consider IgE antibody in proper subset • Treat comorbid illnesses