UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE

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1 Relevance to Population: COPD affects 12 million people in the United States, making it the 4 th leading cause of mortality and the 2 nd leading cause of disability. It is predicted that these statistics will increase by 30% by 2020 due to the aging population and prevalence of tobacco use (Buist et al. 2005). In 2011 COPD was one of the top 10 diagnoses for inpatient admissions of UPMC Health Plan members. Although COPD cannot be cured, use of the following evidence-based guidelines for management of COPD can control symptoms, slow disease progression, and improve quality of life. The prevalence rate for COPD at UPMC Health Plan was nearly 2.0 percent for all products and 7.23% for SNP and 5.53% for Medicare. Definition: Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease with both pulmonary and extra-pulmonary effects. Its pulmonary component is characterized by chronic airflow limitation that is not fully reversible. It is usually progressive and associated with an inflammatory response of the lung to noxious particles or gases. The extra-pulmonary effects, which include weight loss, nutritional abnormalities, skeletal muscle dysfunction, and increased risk for cardiovascular disease, may contribute to the severity of COPD in individual patients. Clinical Indicators Measured by UPMC Health Plan: 1. The percentage of members 40 years of age and older with a new diagnosis or newly active chronic obstructive pulmonary disease (COPD) who received appropriate spirometry testing to confirm the diagnosis. HEDIS 2. The percentage of COPD exacerbations for members 40 years of age and older who had an acute inpatient discharge or ED encounter during the measurement year and who were dispensed appropriate medications Dispensed a systemic corticosteroid within 14 days of the event AND Dispensed a bronchodilator within 30 days of the event. HEDIS Population Covered by Guideline: All adult members with stable COPD and acute exacerbations of COPD. Goals of Therapy Management of COPD and Prevention of Disease Progression: Relieve symptoms Prevent disease progression Improve exercise tolerance Improve health status Prevent and treat complications Prevent and treat exacerbation Reduce mortality Key Points: Spirometry is essential for confirming the diagnosis and classifying the severity of COPD. Spirometry is recommended in all smokers over the age of 40 to establish a diagnosis of COPD. Spirometry should be performed yearly in any patient with a diagnosis of COPD. Spirometry should be considered in asymptomatic patients > 45 y/o who have > 10 pack/year smoking history (patients often ignore or deny symptoms, and COPD is commonly underdiagnosed in its early stages when smoking cessation may be most beneficial). Spirometry can determine level of severity, but other factors, including symptoms, exacerbations, and comorbid conditions, must be accounted for in the determination of therapy for COPD. Spirometry should be performed when the patient is clinically stable and free from infection. Pre-dose and peak FEV 1 should be measured before and after administering a bronchodilator to determine the percentage of reversibility. UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 1

2 Table I - Spirometric Classification of COPD Severity Based on Post-Bronchodilator FEV 1 Assign the patient to the highest severity level in which any feature occurs. Degree of FEV Airflow 1 Ratio Typical Signs and Symptoms (% predicted) Limitation (% predicted) COPD Severity Category I: Mild II: Moderate III: Severe IV: Very Severe Mild airflow limitation Worsening airflow limitation Further worsening of airflow Severe airflow limitation FEV 1 80% 50% < FEV 1 < 80% 30% < FEV 1 < 50% FEV 1 < 30% OR FEV 1 < 50% plus chronic respiratory failure <70% <70% <70% < 70% Chronic cough with or without sputum; Little or no dyspnea Dyspnea developing on exertion; Cough sputum production; General reduction in breath sounds; Presence of wheeze; Hypoxemia may be present Increased shortness of breath with any exertion or at rest; Reduced exercise capacity; Fatigue; Wheeze and cough prominent Presence of chronic respiratory failure; Lung hyperinflation; Cyanosis; peripheral edema; Polycythemia; Hypoxemia and hypercapnea; Cor pulmonale (right heart failure) Key Messages: Treating acute exacerbation (AE) episodes is not sufficient! Prevention and early treatment is critical! Smoking Cessation is the single most effective intervention to reduce the risk of developing COPD and to slow its progression; however, other risk factors, such as occupational dusts and chemicals and indoor air pollution should also be taken into account (GOLD 2007). Oxygen administration long-term > 15 hours/day has been shown to increase survival in patients with hypoxemia. Pharmacotherapy according to Stepwise Therapy can improve clinical outcomes. Any patient with uncontrolled symptoms and or frequent exacerbations of COPD should be referred to pulmonary specialist. Pulmonary rehabilitation, either through a home exercise program for mild disease or a hospital-based program for more advanced disease, is essential to decrease symptoms, exacerbations, and health care utilization. Surgical options such as lung volume reduction surgery can improve symptoms and prolong survival in appropriately selected patients. Living Wills and Durable Powers of Attorney are important to discuss with patients in the long-term management of COPD. UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 2

3 Consequences of acute exacerbations: Negative impact on symptoms and quality of life (Seemungal 2000) Accelerated decline in lung function (FEV 1 ) (Donaldson et al. 2002) Increased mortality with exacerbations (Soler-Cataluna et al. 2005) Increased Health Resource Utilization and Direct Costs (Bourbeau et al. 2003) COPD Management: Key Points about Pharmacotherapy Management of COPD: (GOLD 2007) Inhaled therapy is preferable to systemic therapy. Literacy-sensitive self-management education can result in improved inhaler technique. (Kiser) Most studies indicate that existing medications for COPD do not modify the long-term decline in lung function, but there is limited evidence that regular therapy with LABA, ICS, or both can reduce the decline in lung function (Celli et al. 2008). Bronchodilator medications are central to the symptomatic management of COPD. They are given either on an as-needed basis for relief of persistent or worsening symptoms, or on a regular (GOLD 2007) basis to prevent or reduce symptoms. Principal bronchodilators include 2-agonists, anticholinergics, and methylxanthines used singly or in combination. (GOLD 2007) For acute symptoms, Albuterol is the preferred bronchodilator because of its rapid onset of action. For persistent symptoms, long-acting inhaled bronchodilators (LABA) are more effective and convenient than short-acting agents (GOLD 2007) and are associated with decreased frequency of exacerbations and increased quality of life. Among long-acting anticholinergic bronchodilators, Tiotropium taken once daily is more effective, convenient, and is preferred to Ipratropium taken four times daily. Treatment with long-acting anticholinergic drugs improve the effectiveness of pulmonary rehabilitation. (GOLD 2008) Indacaterol (Arcapta Neohaler) is a 24 hour acting, once daily B2-agonist inhaler that provides sustained bronchodilation, decreased rescue medication use and safety profile similar to placebo. (Feldman) Combining bronchodilators with different mechanisms and durations of action may improve efficacy and reduce the risk of side effects.(gold 2007) o Use of inhaled anticholinergic plus sympathomimetic bronchodilators can result in meaningful increases in lung function even in patients with moderate to severe COPD. (GOLD 2008) Inhaled corticosteroids (ICS) may be used in appropriately selected patients, typically in combination with long-acting bronchodilators in symptomatic moderate to severe COPD. ICS + long-acting inhaled bronchodilators are more effective than either agent used alone; clinical trials have demonstrated this combination results in (Calverly et al. 2007): o Significant improvement in pre-dose bronchodilator and peak FEV 1 o Significant reduction in hospitalizations for COPD exacerbation o Significant improvement in quality of life scores o Trend toward, but not a significant reduction in, mortality from COPD ICS + long-acting beta-agonists + Tiotropium may add further synergism through combined mechanisms of action (anti-inflammation + large airway bronchodilation + small airway bronchodilation). UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 3

4 Inhaled corticosteroids alone or in combination products can increase the risk of pneumonia in COPD patients. Chronic treatment with systemic steroids should be avoided because of an unfavorable benefit to risk ratio. NEW DRUG CLASS: Selective Phosphodiesterase 4 Enzyme Inhibitor (PDE4) Roflumilast (Daliresp) is a once daily oral tablet developed specifically to inhibit COPD related airway inflammation (inhibitation of PDE4 increases intracellular c-amp, which reduces activation of macrophages in response to inflammatory stimuli). (Hertz) Roflumilast has been shown to reduce exacerbations that require steroids in patients with Stage III and IV COPD with repeated exacerbation AND chronic bronchitis. Caution using roflumilast with underlying liver disease and mood disorders/depression (it has been associated with worsening depression and suicidal thoughts). Roflumilast can cause nausea, diarrhea and weight loss in some patients. Review several potential drug-drug interactions with roflumilast before prescribing. INDICATION: For use in adults with severe COPD associated with chronic bronchitis and a history of exacerbations; it should probably be reserved for patients who do not respond to other therapies. (The Medical Letter) Mucolytic Therapy: Evidence for use of mucolytics in COPD is mixed and does not support routine use. Patients with very viscous sputum may receive limited benefit from mucolytics and there is circumstantial evidence they may reduce exacerbations in COPD patients who have not been treated with inhaled glucocorticosteroids. (GOLD 2008) Long-term Antibiotic Therapy to prevent exacerbations: Azithromycin 250 mg P.O. daily added to usual treatment for severe or very severe COPD, decreased the frequency of exacerbations and improved quality of life for up to 1 year (the duration of the study) (Albert et al.) Macrolide antibiotics have both anti-inflammatory and immune modulatory effects. A small percentage of patients on long-term azithromycin experienced decreased hearing. Long-term antibiotic use may change antimicrobial resistance patterns, the effect of which is unknown. Short-term Antibiotic Therapy for acute exacerbations of COPD: (Soto and Varkey) Most patients with COPD exacerbations appear to benefit from antibiotic therapy with improved lung function and decreased treatment failure. Patients with purulent compared to clear sputum are more likely to benefit. Manage COPD with a Stepwise approach according to the severity classification. (GOLD, 2007) Stepwise approach for managing COPD: The Stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. Provide patient education on self-management and controlling risk and environmental factors. COPD Severity Class is a guide for the treatment of COPD, but is not the absolute determinant; severity and persistence of symptoms, frequency of exacerbations and comorbid conditions must also be considered in the selection of optimal therapy. Treatment for stable COPD should be reserved for patients who have respiratory symptoms and FEV 1 less than 60% predicted as documented by spirometry. (Qaseem et al. 2007). Consultation with a pulmonary specialist may be indicated at any stage of the disease to: Confirm the diagnosis Facilitate tobacco cessation Consideration of lung volume reduction or transplantation Optimize treatment if disability progresses, symptoms are uncontrolled, or there are recurrent exacerbations. UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 4

5 Interventions Stratification UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Step Pharmacotherapy recommendations in COPD (Refer to Table II): Mild COPD with intermittent symptoms - manage with short-acting inhaled bronchodilator, e.g., albuterol inhaler. Mild-moderate COPD with FEV1 < 60% predicted and more persistent symptoms manage with maintenance monotherapy using a long-acting inhaled B-agonist, a long acting inhaled anticholinergic, or a combination of both if symptoms are unrelieved by monotherapy. (Qaseem et al. 2007).Moderate-severe COPD with persistent symptoms and/or history of exacerbations Consider combination ICS and inhaled bronchodilator therapy using B-agonist, anticholinergic, or both (triple therapy). (Quaseem et al.2007) Severe or very severe COPD associated with chronic bronchitis and exacerbations with poor control on triple therapy consider adding oral roflumilast. (The Medical Letter) ACUTE EXACERBATIONS of COPD should be treated early and aggressively with: o Oral antibiotics (IV if hospitalization requires) o Oral systemic steroids (IV if hospitalization required) Table II - Therapy at Each Stage of COPD (GOLD 2007) Post Bronchodilator FEV 1 is recommended for the diagnosis and assessment of severity of COPD. I: Mild II: Moderate III: Severe IV: Very Severe < 70% FEV 1 80% predicted < 70% 50% < FEV 1 < 80% predicted <70% 30% < FEV 1 < 50% predicted <70% FEV 1 < 30% OR FEV 1 < 50% predicted plus chronic respiratory failure Active reduction of risk factors; influenza vaccination Add short-acting bronchodilator when needed Pneumococcal vaccine for all COPD patients; ACIP recommends revaccination once > 5 yrs after 1 st dose Add regular treatment with > 1 long-acting bronchodilators (when needed). Add pulmonary rehabilitation.* Consider adding inhaled corticosteroid to long-acting bronchodilator(s) if: Frequent exacerbations Poor symptom control Asthma overlap (Expert opinion Dr. Frank Sciurba) Add inhaled corticosteroids if repeated exacerbations Consider adding Roflumilast P.O. for Stage III or IV COPD associated with chronic bronchitis and history of exacerbations, not responding to other therapies. Add long-term oxygen therapy for chronic respiratory failure** Consider surgical treatments (Lung-Volume Reduction Surgery [LVRS])*** or Lung Transplantation**** UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 5

6 *Pulmonary Rehabilitation: Increase exercise capacity and conditioning. Improve quality of life, Reduce symptoms. Reduce exacerbations and hospitalizations. Presently there is still not sufficient evidence that it improves survival. Evidence-based clinical practice guidelines published in May 2007 issue of Chest recommending the following : Pulmonary rehabilitation should be implemented immediately following a hospital discharge. Long-term programs (12 weeks) that include a home maintenance program have more sustained benefits. Therapy should include a combination of aerobic and strength training to increase muscle strength and muscle mass. Inspiratory muscle training as part of a comprehensive pulmonary rehabilitation program may improve dyspnea, walking distance, and health-related quality of life scores, but multiple study limitations reduce the strength of this recommendation and do not clarify optimal selection of patients or regimens for IMT. (GOLD 2008) (Shoemaker et al.) Oxygen therapy should be used during all exercise for patients who have exercise-induced hypoxemia, but may also be used to increase the endurance of those who do not have exercise-induced hypoxemia during high-intensity workouts. Educational components on self-management and prevention/treatment of exacerbations should be included. (Barclay et al. 2007) Treatment with long acting anticholinergic drugs improves the effectiveness of pulmonary rehabilitation. (GOLD 2008) ** Long-Term Oxygen Therapy: Use of long-term oxygen therapy (> 15 hours per day) should be based on waking PaO2 values. If PaO2 55 mmhg or O2 sat < 88% on RA, with or without hypercapnia OR PaO2 between 55 mmhg and 60mm Hg or O2 sat of 88% if there is: Peripheral edema suggesting pulmonary hypertension; CHF; Polycythemia (Hct > 55%); or Other comorbidity such as mental status changes associated with hypoxemia. Resting hypoxemia should be treated with continuous, 24-hour therapy. Lightweight portable devices are essential to optimize mobility. *** Lung Volume Reduction Surgery: Appears to be beneficial when performed in carefully selected COPD patients and should be performed at CMS certified centers experienced in this procedure. Consider for patients with predominantly upper lobe emphysema and low lung function (FEV 1 less than 45% predicted and significant impairment in quality of life.) Patients should be referred to the LVRS coordinator ( ) for more detailed radiographic, cardiac, and exercise evaluation to determine candidacy. There is evidence of improved outcomes after LVRS, as follows: Increased Pa(O 2 ) and decreased use of supplemental oxygen with exercise, rest and sleep for up to 24 months post-procedure (GOLD 2009). Improved longevity, exercise tolerance and health related quality of life up to 4.3 years post procedure (Naunheim et al. 2006) UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 6

7 Reduced frequency of COPD exacerbations and increased the time to first exacerbation. (GOLD 2008) (Washko et al.) **** Lung Transplantation: Consider for COPD patients with very severe disease who meet lung transplant criteria and have no contraindications to the surgery. Such patients should be referred to the UPMC Lung Transplant Center for evaluation. Table III - Pharmaceutical Interventions for Inhaled Agents and Dosing Information Generic Name Brand Drug Category Dosing Information & Comments Name 2 AGONIST Short-acting Albuterol 2-4 puffs as needed every 4-6 hours Levalbuterol Ventolin HFA, Proventil HFA, Proair HFA Short-acting 2 agonist Xopenex HFA Short-acting 2 agonist Albuterol + Short-acting Ipratropium Combivent 2 agonist + short-acting anticholinergic 2 AGONIST Long-acting Salmeterol Serevent Discus Long-acting 2 agonist Formoterol Foradil Long-acting 2 agonist Indacaterol Arcapta 24-hour long-acting Neohaler 2 agonist ANTICHOLINERGICS Ipratropium Atrovent Short-acting anticholinergic Tiotropium Spiriva Long-acting anticholinergic INHALED CORTICOSTEROID 2 puffs every 4-6 hours (theoretical benefits over Albuterol not demonstrated; 3 rd line after Albuterol & Ipratropium in COPD) 2-4 puffs QID; greater bronchodilation effect than each alone, but similar effect probably achieved by doubling the dose of each drug 1 puff BID; higher and longer bronchodilation effect than other 2 agonists 1 puff BID; similar to Salmeterol, but has quicker onset of action 75 mcg once daily, dry powder capsule for inhalation with the Neohaler 2-4 puffs QID; maintenance only, not PRN for acute symptoms 1 capsule inhaled daily; replaces Ipratropium Beclomethasone Qvar Inhaled 1-8 puffs (40-320mcg) twice daily Budenoside DPI Pulmicort Inhaled 1 8 puffs ( mcg) daily divided in 2 doses Flunisolide Aerobid Inhaled 2 8 puffs ( mcg) daily divided in 2 doses Fluticasone 44 Flovent 44 Inhaled 2 6 puffs ( mcg) daily divided in 2 doses Fluticasone 110 Flovent Inhaled 2 16 puffs ( mcg) daily divided in UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 7

8 Generic Name Brand Drug Category Dosing Information & Comments Name doses Fluticasone 220 Flovent 220 Inhaled 2 8 puffs ( mcg) daily divided in 2 doses Mometasone Asmanex Inhaled 1-2 puffs ( mcg) once or twice daily Ciclesonide Alvesco Inhaled 1-4 puffs (80mcg-320mcg) twice daily Combination longacting Fluticasone 100 Advair + Salmeterol /50 2 agonist + 1 puff (100 mcg Fluticasone + 50 mcg Inhaled Salmeterol) every 12 hrs Fluticasone Salmeterol 50 Fluticasone Salmeterol 50 Formoterol/ Budesonide Advair 250/50 Advair 500/50 Symbicort Combination longacting 2 agonist + Inhaled Combination longacting 2 agonist + Inhaled Combination longacting 2 agonist + Inhaled Phosphodiesterase 4 Enzyme (PDE4) Inhibitor - systemic/oral therapy 1 puff (250 mcg Fluticasone + 50 mcg Salmeterol) every 12 hrs 1 puff (500 mcg Fluticasone + 50 mcg Salmeterol) every 12 hrs 2 puffs(80-160mg/4.5mg) twice daily Roflumilast Daliresp PDE4 Inhibitor 500 mcg once daily, taken P.O. It is important to note, the pharmacy coverage can vary based on the members plan. Therefore it is recommended that the office confirm coverage through the pharmacy to determine covered plan benefits. Oxygen Therapy: Long-term oxygen therapy (more than 15 hours per day) improves survival and quality of life in hypoxemic patients: PaO2 < 55 mmhg/sao2 < 88% on RA with or without hypercapnea OR PaO2 of mmhg/sao2 of 88% with coexisting pulmonary hypertension, peripheral edema suggesting CHF, or polycythemia (Hct > 55%). 9 Pulse oximetry is useful to monitor oxygen saturation and to adjust the oxygen flow setting. Titrate oxygen to a flow rate sufficient to maintain PaO2 > 60mmHg/SpO2 > 90% with exercise.(gold 2007) Consider overnight pulse oximetry and/or referral for sleep evaluation if nocturnal/sleep desaturation is suspected. ABG measurement should be considered to initiate oxygen therapy and/or to assess for hypercapnea in the following clinical circumstances: Clinical suspicion of hypercapnea (asterixis, headache, hypersomnolence, altered mental status) FEV1 < 1.0 Morbid obesity Excessive daytime somnolence Right heart failure/corpulmonale Severe airflow obstruction UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 8

9 Brief Strategies to Help the Patient Willing to Quit Smoking: ASK: Systemically identify all tobacco users at every visit. ADVISE: Strongly urge all tobacco users to quit. ASSESS: Determine willingness to make a quit attempt. ASSIST: Aid the patient in quitting. ARRANGE: Schedule follow-up contact. For additional information go to Clinical practice guidelines are designed to assist clinicians by providing a framework for the evaluation and treatment of patients. Additional Resources for UPMC Health Plan Members MyHealth Advice Line is staffed by experienced Registered Nurses and is available 24/7 to provide telephone support to members. Call TTY/TDD users should call Health Coach Programs provide intensive case management for members with specific chronic illnesses or conditions. The programs are built upon best practices and accepted clinical guidelines and include: Diabetes Asthma/COPD Behavioral Health Depression Anxiety ADHD Substance Abuse Cardiovascular Heart failure Coronary artery disease Hypertension Hyperlipidemia. Low Back Pain Members and providers can obtain additional information about the health coach programs by calling Online interactive preventive health programs and resources are available in partnership with WebMD at MyHealth OnLine Tobacco Cessation Program MyHealth OnLine Physical Activity Program MyHealth OnLine Nutrition Program MyHealth OnLine Weight Management Program MyHealth OnLine Stress Management Program MyHealth OnLine Emotional Health Program UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 9

10 Scientific Evidence Sources: Albert RK et al. Azithromycin for Prevention of Exacerbations of COPD. New England Journal of Medicine. August 25, 2011;365: Barclay L, et al. New Guidelines Highlight Benefits of Pulmonary Rehabilitation. Chest, 2007:131:4S-42S. O Reilly P, et al. Long-term Continuous Oxygen Treatment in Chronic Obstructive Pulmonary Disease: Proper Use, Benefits and Unresolved Issues. Curr Opin Pulm Med. 2007; 13(2): Bourbeau J. "Self-Management of Acute Exacerbations." Clinical Consensus on COPD, 2-3rd March 2007, Presentation. AE is to COPD what MI is to CAD! slide # 12. Bourbeau J et al. Reduction of hospital utilization in patients with chronic obstructive pulmonary disease: a disease-specific self-management intervention. Archives of Internal Medicine March 10; 163(5): Buist AS, et al. The Burden of Obstructive Lung Disease Initiative (BOLD): Rationale and Design. J COPD 2005; 2: Calverley PM. Inhaled Therapy and Prevention of Exacerbations. TORCH NEJM; 2007 Feb. 21. Calverley PM et al. Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease. New England Journal of Medicine February 22; 356(8): Cazzola M, et al. Salmeterol/Fluticasone Propionate in a Single Inhaler Device Versus Theophylline + Fluticasone Propionate in Patients with COPD. Pulmonary Pharmacology and Therapeutics. 2004; 17: Celli BR et al. Effect of Pharmacotherapy on Rate of Decline of Lung Function in Chronic Obstructive Pulmonary Disease; Results from the TORCH Study. American Journal of Respiratory and Critical Care Medicine 2008 August 15;178(4): Donaldson GC, et al. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax Oct;57(10): Donohue JF, et al. A 6-month, Placebo-controlled Study Comparing Lung Function and Health Status Changes in COPD Patients Treated with Tiotropium or Salmeterol. Chest, 2002 July; 122(1): Feldman G et al. Efficacy and Safety of Indacaterol 150 Microgram Once-Daily in COPD: A Double-Blind, Randomised 12-Week Study. BioMedical Central Pulmonary Medicine. 2010;10(11):1-9. Global Initiative for Chronic Obstructive Lung Disease; Institute for Clinical Systems Improvement Health Care Guidelines for Chronic Obstructive Pulmonary Disease (2010). Global Initiative for Chronic Obstructive Lung Disease; Institute for Clinical Systems Improvement Health Care Guidelines for Chronic Obstructive Pulmonary Disease (2009). Global Initiative for Chronic Obstructive Lung Disease; Institute for Clinical Systems Improvement Health Care Guidelines for Chronic Obstructive Pulmonary Disease (2007). Hertz A et al. Elevated Cyclic AMP and PDE4 Inhibition Induce Chemokine Expression in Human Monocyte- Derived Macrophages. Proceedings of the National Academy of Sciences. December 22, 2009;106(51): UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 10

11 Kiser K et al. A Randomized Controlled Trial of a Literacy-Sensitive Self-Management Intervention for Chronic Obstructive Lung Disease. Journal of General Internal Medicine September 21;Epub ahead of print: Naunheim et al. Long-Term Follow-up of Patients Receiving Lung-Volume-Reduction Surgery Versus Medical Therapy for Severe Emphasema by the National Emphasema Treatment Trial Research Group. Annals of Thoracic Surgery, 2006;82(2): Niewoehner DE, et al. Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease with Tiotropium, a Once-Daily Inhaled Anticholinergic Bronchodilator. Annals of Internal Medicine, 2005; 143: Qaseem A et al. Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 2007 ;147: Sciurba FC. COPD Diagnosis and Management, Conference: Advances in primary care. Primary Care Network, Seemungal. Effect of Exacerbation on Quality of Life in Patients with Chronic Obstructive Pulmonary Disease. AJRCCM 1998 and 2000 (Spencer. Thorax; 2003). Shoemaker MJ et al. "Systematic Review - Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease: State of the Evidence." Cardiopulmonary Physical Therapy Journal. September, 2009;20(3):5-15. Soler-Cataluna et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 2005; 60: Soto FJ and B Varkey. Evidence-Based Approach to Acute Exacerbations of COPD. Current Opinion in Pulmonary Medicine. 2003;9(2):1-7. The Medical Letter, Inc. Roflumilast (Daliresp) for COPD. The Medical Letter on Drugs and Therapeutics. July 25, 2011;53(1369): Van Noord JA, et al. Effects of Tiotropium With and Without Formeterol on Airflow Obstruction and Resting Hyperinflation in Patient with COPD. Chest, 2006;129: Van Noord JA, et al. Effects of Tiotropium With and Without Formeterol on Airflow Obstruction and Resting Hyperinflation in Patient with COPD. Chest, 2006;129: Washko GR et al. "The Effect of Lung Volume Reduction Surgery on Chronic Obstructive Pulmonary Disease Exacerbations." American Journal of Respiratory and Critical Care Medicine : UPMC HEALTH PLAN COPD CLINICAL PRACTICE GUIDELINE Page 11

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