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Description : This medical presentation titled ""Asthma Management Pharmacological Therapy"" is about asthma classification schemes, stepwise approach to asthma therapy, asthma medications and delivery devices, and new/complementary/alternative asthma therapies.

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Slide 1-

Asthma Management Pharmacological Therapy Presented by: Hengameh Raissy, PharmD
Slide 2-

Four Components of Asthma Management Assessment and Monitoring Control of Factors Contributing to Asthma Severity Education for a Partnership in Asthma Care Pharmacological Therapy NAEPP. EPR-3, page 1.
Slide 3-

This lesson will cover:
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Asthma is a chronic inflammatory disorder of the airways A key principle of therapy is regulation of chronic airway inflammation What is Asthma? Bronchospasm is what you see as cough and wheeze Inflammation is what you don’t see but is at the center of the process
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Pathophysiology of Asthma INFLAMMATION Airway Hyperresponsiveness Airflow Limitation Environmental Risk Factors Genetic Predisposition Symptoms Cough Wheeze Shortness of Breath Adapted with permission from Stephen T. Holgate, MD, D. Sc. bronchospasm Precipitants
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The Pharmacological Treatment of Asthma can focus on one or both aspects of the disease…
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Asthma: The Chronic Disease
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The Risk of Asthma in a Wheezing Child 0-3 years: Modified Asthma Predictive Index - strict API = NPV ≥ 95% no asthma +strict API = 9.8x likely to have active asthma when 6-13y/o +loose API= 5.5x likely to have active asthma when 6-13 y/o Guilbert TW, et al JACI 2004 OR In the past 12 months, >3 episodes of wheezing with at least
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Classifying Asthma Severity: 0 – 4 years The Chronic Disease Classifying severity in children who are not currently taking long-term control medication.
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Step 1 Preferred: SABA PRN Step 2 Preferred: Low-dose ICS Alternative:Cromolyn or Montelukast Step 3 Preferred: Medium-dose ICS Step 5 Preferred: High-dose ICS + either LABA or Montelukast Step 6 Preferred: High-dose ICS + either LABA or Montelukast OSC Step 4 Preferred: Medium-dose ICS + either LABA or Montelukast Initial Therapies / Stepwise Approach: Asthma Patients 0-4 Years of Age ICS = inhaled corticosteroid; LABA = long-acting beta2-agonist; OSC = Oral Systemic Corticosteroids.; SABA = inhaled short-acting beta2-agonist. Consider consult Recommend consult Mild Moderate Severe A D D D D Intermittent Persistent Each Step: Patient education, environmental control, management of co morbidities If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up Step Down If Possible (and asthma is well controlled at least 3 months) Step Up If Needed (first, check adherence, inhaler technique, environmental control) Assess Control
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Assessing Control: 0 – 4 years
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Classifying Asthma Severity: 5 – 11 years The Chronic Disease Classifying severity in children who are not currently taking long-term control medication.
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Step 1 Preferred: SABA PRN Step 2 Preferred: Low-dose ICS Alternative:Cromolyn LTRA Nedocromil or theophylline Step 3 Preferred Medium-dose ICS OR Low-dose ICS + either LABA, LTRA or theophylline Step 5 Preferred: High-dose ICS + LABA Alternative: High dose ICS + either LTRA or theophylline Step 6 Preferred: High-dose ICS + LABA + OSC Alternative: High dose ICS + either LTRA or Theophylline +OSC Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS +either LTRA or theophylline Initial Therapies / Stepwise Approach: Asthma Patient 5-11 Years of Age Persistent Intermittent Each Step: Patient education, environmental control, management of co morbidities Steps 2-4: Consider subcutaneous allergen immunotherapy for patients with allergic asthma Consider consult Recommend consult Mild Moderate Severe A B B B D ICS = inhaled corticosteroid; LABA = long-acting beta2-agonist; LTRA= leukotriene receptor antagonist; OSC = Oral Systemic Corticosteroids; SABA = short-acting beta2-agonist. Step Down If Possible (and asthma is well controlled at least 3 months) Step Up If Needed (first, check adherence, inhaler technique, environmental control) Assess Control
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Asthma Control: 5 – 11 years
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Classifying Asthma Severity: 12 and older The Chronic Disease Classifying severity for patients who are not currently taking long-term control medication.
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Step 1 Preferred: SABA PRN Step 6 Preferred: High-dose ICS + LABA + OSC And Consider Omalizumab for patients who have allergies Initial Therapies /Stepwise Approach: Asthma Patients > 12 Years of Age ICS = inhaled corticosteroids; OSC = Oral Systemic Corticosteroids; SABA = short-acting beta2-agonist; LABA = long-acting beta2-agonist; LTRA= leukotriene receptor antagonist. Persistent Intermittent Each Step: Patient education, environmental control, management of co morbidities Steps 2-4: Consider subcutaneous allergen immunotherapy for patients with allergic asthma Consider consult Recommend consult Mild Moderate Severe Step Down If Possible (and asthma is well controlled at least 3 months) Step Up If Needed (first, check adherence, inhaler technique, environmental control) Assess Control A A/B/D B/D B B Step 1 Preferred: SABA PRN Step 2 Preferred: Low-dose ICS Alternative:Cromolyn LTRA or theophylline Step 3 Preferred: Medium-dose ICS or Low-dose ICS + LABA Alternative: Low dose ICS + LTRA, theophylline or zileuton Step 5 Preferred: High-dose ICS + LABA And Consider Omalizumab for patients who have allergies Step 4 Preferred: Medium-dose ICS + LABA Alternative: medium dose ICS + LTRA, theophylline or zileuton
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Asthma Control: 12 and older
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Severity assessment has been simplified and lung function measurement is emphasized Lower doses of systemic corticosteroids (OCS); 1mg/kg may be enough Education on site and as part of discharge plan Initiation of controller inhaled corticosteroids (ICS) for persistent asthma recommended If hospitalized, ipratropium is not recommended (2 studies) What’s New: The ED / Hospital NAEPP. EPR-3, pages 102-106.
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Severity Assessment of Acute Flares
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Classifying Severity- of Acute Disease (Asthma Exacerbations)
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Managing Asthma: Acute Exacerbations Impending respiratory failure: oxygen; iv access; alb/atrovent; bolus solumedrol; admit to ICU; prepare for intubation Severe: oxygen; 3 albuterol nebs w/ atrovent or continuous albuterol; i.v. or oral methylpred 1-2 mg/kg admit to hospital Moderate: oxygen; albuterol nebulization q 20 min x 3; oral corticosteroids 1-2 mg/kg for 3-5 days; treat co-morbidities Mild: albuterol MDI (w/ spacer), or nebulizer treatment up to 3 times; consider oral corticosteroid The Acute Disease
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Medications
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Inhaled Medication: In general, inhaled therapy is favored over systemic (oral) therapy for asthma The medication is delivered on site and avoids most adverse side effects Pharmacological Therapy NAEPP. EPR-3, page 216.
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Inhaled Medication Delivery Devices
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Many MDIs used chlorofluorocarbons (CFCs) as propellants. CFCs were phased out globally in 2008 to protect the earth’s ozone layer Hydrofluroalkaline (HFA) inhalers are the non-CFC alternative DPIs (breath actuated Dry Powder Inhalers) are non-CFC compliant Metered Dosed Inhalers Transition to non-CFC containing inhalers:
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Daily Long-Term Control: Corticosteroids (inhaled and systemic) Long-acting beta2-agonists (salmeterol, formoterol) when in combination with ICS Leukotriene modifiers (montelukast) Leukotriene inhibitors (zileuton) Mast cell stabilizers (cromolyn or nedocromil) Methylxanthines (theophylline) Overview of Asthma Medications
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Inhaled Corticosteroids (ICS): Most effective long-term-control therapy for persistent asthma Risk for adverse events is minimal at recommended low/medium inhaled doses Risk depends on dose and delivery method Long-Term Control
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Benefit of daily use: Reduced airway inflammation Improved lung function Reduced use of quick-relief medicine Fewer symptoms and exacerbations In usual doses ICS do not provide short-term relief Must be used daily for full benefit Inhaled Corticosteroids
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Rate Ratio for Death from Asthma No. of Canisters of Inhaled Corticosteroids per Yr. 2.5 2.0 1.5 1.0 0.5 0.0 1 2 3 4 5 6 7 8 9 10 11 12 Low-dose ICS and the Prevention of Death from Asthma Suissa S et al. N Engl J Med. 2000;343:332-336.
Slide 30-

Effects of Inhaled Steroids on Airway Inflammation J Allergy Clin Immunol. 1992;90:32-42. Pre– and post–3-month treatment with budesonide (BUD) 600 mcg b.i.d. E = Epithelium; BM = Basement Membrane
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Possible Dose-Dependent side effects: Oral candidiasis (thrush) Dysphonia Reflex cough and bronchospasm Slowed linear growth velocity Decreases in bone mineral density Dermal thinning and skin bruising Ocular effects: glaucoma, cataracts Inhaled Corticosteroids
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CAMP Trial and Follow-up Design Routine Care Randomize Treatment Trial Transition 5 visits 3 visits per year 2 visits Study Rx Discontinued 2 - 4 months 4 – 6 years 4 months Screening and Baseline 13 years Follow-up Enroll in follow-up study Refer back to PCP for Rx per NAEPP guidelines Nedocromil Budesonide Placebo Enrollment in trial: Dec 1993 – Sept 1995 1,041 children age 5-13 years at randomization Mild to moderate persistent asthma 1-4 visits per year
Slide 33-

Change in Bone Density at End of CAMP Trial Budesonide vs. Placebo = - 0.01, P = 0.53 Nedocromil vs. Placebo = - 0.01, P = 0.15 Budesonide Nedocromil Placebo (n = 304) (n = 306) (n = 410)
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Mean Obtained Adjusted Adult Height -1.2 cm (-1.9 to -0.5) -1.8 cm (-2.9 to -0.7) -0.8 cm (-1.8 to 0.2) cm *Means adjusted for race/ethnicity, clinic, and age, asthma duration and severity, skin test reactivity, and height at trial entry. Total panel also adjusted for sex. Bud–Plbo diff.: (95% CI) Bud by sex interactio, P=0.10 Bud vs Plbo: P=0.001 P=0.001 P=0.10 Ned vs Plbo: P=0.61 P=0.26 P=0.98
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ICS Metabolism
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Reduce potential for adverse events by: Rinsing mouth Using lowest dose possible that results in control Use in combination with long-acting beta2-agonists (LABA) or a leukotriene modifier if moderate/severe disease Inhaled Corticosteroids
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Comparative Dosages: HFA ≠ DPI ≠ MDI ≠ respules Preparations are not equivalent per puff or per microgram Comparative doses are estimated. Few data directly compare preparations Inhaled Corticosteroids
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Chemical Structure of Inhaled Corticosteroids
Slide 39-

Mometasone (Asmanex) Beclomethasone (QVAR) Budesonide (Pulmicort) Flexhaler: 90, 180 40, 80 ug/puff 110, 220 ug/puff Budesonide (Pulmicort) .5mg, 1.0mg 110 ug/puff 220 ug/puff 44 ug/puff Fluticasone (Flovent HFA) Inhaled Corticosteroids
Slide 40-

Estimated Comparative Daily Dosages of Inhaled Corticosteroids for Adults
Slide 41-

Long-Acting Beta2-Agonists (LABA) salmeterol (serevent), formoterol (foradil) May be beneficial when added to inhaled corticosteroids as an adjunct Do not have anti-inflammatory properties alone Asthma may worsen if used as mono-therapy LABA’s are not recommended for use as mono-therapy for long term control of persistent asthma Not appropriate for quick relief
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28 week, randomized, double-blind, placebo-controlled; 164 patients; 12 - 65 yrs. old Persistent asthmatics controlled on Triamcinolone 400 mcg bid Use of Salmeterol Alone to Treat Asthma JAMA 2001;285:2583-93. Treatment Failure Rate Treatment arms: Placebo Change to Salmeterol Continue ICS
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Is there a problem with inhaled long-acting B-adrenergic agonists (LABA)? Harold Nelson, MD LABA’s by themselves have no significant anti-inflammatory effects and should be used with ICS When used with ICS most studies have not identified an increased risk of death or near death from asthma Re-analysis of the pattern of asthma deaths suggest that in patients with limited access to care, symptomatic relief provided by LABA’s may result in delays in seeking medical care in the face of increasing airway inflammation J Allergy Clin Immunol Jan. 2006
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Leukotriene Modifiers Mechanisms 5-LO inhibitors –zileuton (Zyflo) Cysteinyl LeukoTriene Receptor Antagonists montelukast (Singulair), zafirlukast (Accolate) Indications Monotherapy in mild persistent asthma Add-on therapy in moderate to severe persistent asthma Long-Term Control
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Combination Therapy MDI 100/5 mcg 200/5 mcg Patients 12 and older Dulera Momestasone Furoate Formoterol Fumarate
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Combination Therapy MDI 80/4.5 mcg 160/4.5 mcg Patients 12 and older Symbicort Budesonide Formoterol Fumarate
Slide 47-

Advair® DPI Doses: 100/50* mcg 250/50 mcg 500/50 mcg -DPI: Breath Actuated Dry Powder Inhaler MDI HFA Fluticasone propionate and samleterol *approved > 4 yrs The rest of the doses are approved for 12 years and older MDI doses 45/21 mcg 115/21 mcg 230/21 mcg
Slide 48-

Why use fixed combinations? The asthmatic who needs moderate persistent therapy and who has failed on appropriate doses of inhaled corticosteroids The challenging patient Facilitate compliance Decrease the number of inhalation devices Improve patient inventory control DO NOT use unless both medications are necessary to control asthma….
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Currently Approved Controller Therapy for Asthma in Children FDA-Approved Ages (Years) for Use in Children 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Triamcinolone Flunisonide Fluticasone and Salmeterol DPI Nebulized Budesonide Budesonide DPI Montelukast Beclomethasone HFA Mometasone DPI Budesonide and Formoterol DPI
Slide 50-

Role of Leukotrienes in Asthma Adapted from Hay DWP et al. Trends Pharmacol Sci 1995;16:304-309
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Oral pharmacokinetics: Rapidly and well absorbed Not affected by food ingestion Minimal accumulation with multiple dosing No dosage adjustments required based on: Renal insufficiency Mild to moderate hepatic insufficiency The elderly Anecdotal Reports: Recent reports about behavioral side effects Montelukast (Singulair)
Slide 52-

Cherry-Flavored Chewable Tablets 4 mg 5 mg Ages 2–5 Ages 6–14 Montelukast (SINGULAIR™†) (montelukast sodium, MSD) Administered once daily ( bedtime) Available for adults and children as young as 6 months †Trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA Film-Coated Tablet 10 mg Ages  15 years Granule Packets 4mg Ages 6 mos–5yrs C.A.I.R Dosing Regimen in Adults and Children
Slide 53-

Urgent control of Inflammation Systemic corticosteroids (IV or PO) Burst Tx (PO) or hospitalization/ER (IV) As-needed: Quick Relief Short-acting (selective) beta2-agonists (albuterol, pirbuterol, levalbuterol) Anticholinergics (Ipratropium bromide) Short-acting Asthma Medications
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ProAir Proventil HFA Ventolin HFA Albuterol HFA Levalbuterol (Xopenex HFA) Pirbuterol (Maxair) Quick Relief Beta2-agonists Nebulizer Solutions
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Quick Relief * available as HFA MDI and in several nebulizer forms * * available as breath actuated brand name MDI * * * available as HFA MDI or liquid for nebulization (.31mg, .63mg, 1.25mg)
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Short-Acting Beta2-Agonists: Regularly scheduled use is not generally recommended May lower effectiveness and increase side effects May increase airway hyper-responsiveness Using >2 canisters per month-risk factor for death NAEPP. EPR-3, page 377.
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Older adults: Older adults esp. those with ischemic heart disease may show Increased sensitivity to B-agonists (tremor, tachycardia) Systemic corticosteroids can provoke: confusion agitation changes in glucose metabolism Inhaled corticosteroids May be associated with dose-dependent reduction in bone mineral content Physician may consider concurrent treatment with Calcium supplements and Vitamin D Bone-sparing medications (e.g. bisphosphonates) Special Considerations
Slide 58-

Patients with other medical issues: Medications for other diseases may exacerbate asthma NSAIDs (ASA induced asthma) Nonselective beta-blockers Beta-blockers found in some eye drops ACE inhibitors Special Considerations
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Transient narrowing of the airways associated with: Physical exertion Coughing, wheezing or shortness of breath occurring within 10-15 minutes of starting exercise: Exercise duration = 2-8 min. (85-95% max HR) Maximal at 8-15 minutes post exercise Diagnosis = 12-15% drop in FEV1 (7% in elite athlete) Special Considerations Exercise Induced Asthma (EIA) Exercise Induced Bronchospasm (EIB)
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Occurrence: 90% of asthmatics 40% of patients with allergic rhinitis 22% of 1998 Olympic athletes 9% of persons with EIB have no hx of asthma or allergies 10-50% of asthmatics on ICS still display EIB Exercise Induced Asthma
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Management Strategies: Short-acting inhaled beta2-agonists used shortly before exercise last 2 to 3 hours Salmeterol may prevent EIB for 10 to 12 hours Cromolyn if side effects a concern A lengthy warm-up period before exercise An aerobic conditioning program Long-term-control therapy, if appropriate Avoid asthma triggers during exercise Managing Exercise-Induced Asthma
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Over-The-Counter (OTC) Asthma Medicines: Always include OTC’s in medical history OTC products may provoke asthma (ASA) Short acting bronchodilators (e.g. Primatene mist): not a substitute for prescription medicines Often indicate need for physician referral Very short acting and non-selective Special Considerations
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Subcutaneous Allergy Immunotherapy
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Subcutaneous Allergen Immunotherapy is considered for: NAEPP. EPR-3, page 177.
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Newer Therapy Anti-IgE Therapy – Omalizumab (Xolair) Humanized IgG (5% murine) Binds IgE regardless of specificity Does not activate complement Rarely has caused anaphylaxis
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Indicated for adults and adolescents(>12) with severe persistent asthma inadequately controlled on high-dose ICS and LABA Selected patients must have a positive skin test or in vitro reactivity to aeroallergens Dosed every 2-4 weeks; SQ dosing May allow these patients to improve control, decrease dose of ICS and decrease reliance on oral corticosteroids Xolair (Omalizumab)
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Use of Alternative medicines may result in: allergic reactions intensification of drug side effects Users may not be aware of: potency contaminants covert additives Recommended that clinician ask patient about complementary and alternative medicine use (CAM) Alternative Therapies NAEPP. EPR-3, pages 240 - 244. 40% of pts who use non-provider prescribed therapies do not report alternative medication use because they are not asked or because they do not think it is important for their medical provider to know (Eisenberg 2001).
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According to the 2007 NAEPP EPR-3: NAEPP. EPR-3, pages 240 - 242.
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However, some people find these therapies helpful:
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Potential for Allergic Responses Daisy family Horse chestnut Natural plant salicylates Royal jelly Alternative Medicines Willow bark Royal Jelly Echinacea
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Intensification of Drugs CNS stimulants Ma huang (ephedra) Ginseng Yohimbe Goldenseal Gingko Potentiate steroids Licorice Alternative Medicines Ginseng
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Deactivation of Drugs Decreases theophylline levels St John’s wort Decreases prednisolone levels xiao hu tang sho-saiko-to Alternative Medicines St. John’s Wort
Slide 73-

Focus is on treating inflammation Severity classification of the chronic disease determines therapy Inhaled corticosteroids are the best therapy for treatment of persistent disease New therapies on the horizon …. Updates on the guidelines are the best resources Asthma Pharmacological Therapy
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Asthma Management Pharmacological Therapy: Case Studies Presented by:
Slide 75-

Case Study #1 Mild – Moderate Persistent Inhaled Corticosteroids - Asthma education Very Likely
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Case Study #2 Not well controlled Switch to Inhaled Corticosteroid Assess adherence; evaluate for co morbidities; educate Follow-up in 2-6 weeks
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Case Study #3 Moderate Persistent Budesonide DPI 180 2 puffs bid or Budesonide 180 1 puff bid with Montelukast 5 mg or Advair 100/50 1 puff bid—consider black box warning Check technique Write an action plan; Provide asthma self-management education; assess triggers; consider referral to an asthma specialist Bring her back in 2-6 weeks
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Case Study #4 Check pre and post spirometry Perform exercise challenge Consider more in depth studies and co morbidities Consider asthma specialist consultation You could try combination therapy but the work-up is most important
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Case Study #5 Of course Oral corticosteroids; evaluate for co-morbidities Probably; need more family/personal history
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Barbara Chilmonczyk, MD Allergy and Asthma Associates of Maine; AH! Asthma Health Program Director, MaineHealth and the Barbara Bush Children’s Hospital @ Maine Medical Center, Portland, ME (207) 662-3325 Rhonda Vosmus, RRT-NPS, AE-C Asthma Education Specialist Maine Medical Center and MaineHealth, Portland, ME (207) 662-4515 Janice H. Howell, MD, FRCPC, FAAP Faculty Physician, Medical Education-Pediatrics, Orlando FL (321) 841-2121 Chris Garvey, FNP, MSN, MPA, FAACVPR Manager Pulmonary and Cardiac Rehabilitation Seton Medical Center (650) 991-6776 Donna Beal, MPH, CHES Regional Program Director ALACA Santa Barbara, CA (805) 963-1426 NIH. NAEPP Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma, October 2007. Acknowledgements
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