AstraZeneca – Call For Grants – 2011 Web-based EnduringPrograms(CGA RESP 1102)

Therapeutic Area: Respiratory

Disease State: Asthma & COPD

Call for Grants Application Title: “CGA RESP 1102 – Program Title…”

•Your title must begin with Call for Grants Application (CGA) ID number.

•Refer to Grant Submission Instructions for further information on submitting your formal grant application.

Submission Timeframe: / 1/3/2011 – 3/31/2011
Proposal: / Support for CME based educational initiatives focusing on the diagnosis and treatment of people with asthma & COPD.
Educational Audience: /
  • Allergists, pulmonologists, PCP’s, and other healthcare professionals
  • Specialists and generalists who diagnose, treat, and manage adult patients with asthma and /or COPD

Program Format: / Educational platformto include web-based enduring channels
Program Cost: / $100,000.00 (Multi-support is preferable)

AstraZeneca is interested in providing grant support for independent education activities in the area of Asthma & COPDthat address the comparative safety and efficacy of treatment options, increase awareness and adherence to treatment guidelines, and provide evidence-based solutions to meeting the unmet medical need with existing therapies.

Needs Assessment: For Asthma

Asthma is a chronic, respiratory illness that affects an estimated 16.2 million individuals in the United States (NCHS.FASTATS for asthma, 2008). The morbidity & mortality associated with asthma results in a significant burden to the healthcare system. Between 1989 and 2004, the number of physician office visits for asthma rose from ~6 million to nearly 15 million a year. Hospitalization for asthma as a secondary diagnosis rose sharply during that same time period going from 400,000 to ~1.4 million (NHLBI, 2007). The economic costs also continue to skyrocket, estimated at $19.7 billion in direct & indirect costs each year (NHLBI, 2007).

According to the National Committee for Quality Assurance (NCQA) many asthma- related costs could be avoided with the appropriate medical management (NCQA, 2007). Although evidence-based guidelines exist for asthma diagnosis & management, adherence to these guidelines is suboptimal, which contributes to a significant variation in asthma outcomes (Lougheed, 2007 & Klomp, et al. 2008).

A survey conducted in 2008 for National Jewish as part of their CME work demonstrated that primary care physicians identified patient non-adherence and the need for multiple medications to control allergic asthma symptoms as the most important barriers to their patient management. They also demonstrated only a moderate level of confidence in their current understanding of the pathophysiology of allergic asthma and the role of ICS in the treatment of this diagnosis, as well as their level of confidence in the evidence-based pharmacotherapy for asthma patients (Outcomes Inc., 2008).

In August of 2007, the newest update to the National Asthma Education & Prevention Program (NAEPP), “Guidelines for the Diagnosis & Management of Asthma” (EPR-3) were released. Because of the breadth of information contained in this document, many physicians were unable to clearly identify important information, or to locate an actual step-wise chart (Lagerlov, 2006). One of the most effective ways to disseminate guidelines involves multi-faceted clinician education programs based on interactive learning methods; such education can significantly improve the overall quality of care for patients with asthma (Cabana, 2006).

The reasons for classifying asthma include the clinical perspective of appropriate pharmacotherapy. Preferably asthma classification should also provide a guide to treatment with the potential to alter the natural history of the disease (LeRoy, 2006).

In order for any classification to be useful, it needs to be assumed that the person making the diagnosis can accurately and reliably diagnose asthma correctly (LeRoy, 2006). A number of previous studies have found dissociation between asthma severity based on symptoms and measure of lung function (Fuhlbrigge, 2004).

Spirometry is an objective measurement that can accurately evaluate air flow obstruction and is a highly guideline-recommended tool for diagnosing and managing asthma & COPD (Denlinger, et al., 2007). Despite the positive reasons for the routine use of spirometry, it is well recognized that spirometry is underutilized (Yawn, 2007). Moore (2007) found that primary care physicians under use spirometry as a diagnostic tool even when it is available in the physician’s office or clinic setting.

Assessments of asthma severity and control are important as the components of “personalized medicine” become more prominent in asthma management. Personalized medicine incorporates the use of genetic information as well as the efficacy, safety, and cost of individual therapies in order to produce the best treatment outcomes (Schreck, 2006).

The Quality Gap to be addressed:

The needs assessment implies that optimal care for patients with asthma must include the use of spirometry to accurately diagnose the severity of the disease, so that the proper treatment regimen can be provided. Many primary care physicians have reported a lack of awareness of the practice guidelines on spirometry for the differential diagnosis of asthma vs. COPD (Barr, 2005). Previously published surveys have shown that a large portion of both asthma & COPD diagnosis are made without an objective airway measure of airway obstruction (Zanconato, et al., 2005). Providers have demonstrated their hesitancy in providing spirometry in their office related to issues with costs, correct operator usage, and reliability (Mortimer, et al., 2003).

The ability to correctly diagnose the type of obstructive airway disease, as well as its severity, and to use the information to choose appropriate therapies for these patients is critical.

Cited References

  1. Barr RG, Celli BR, Martinez FJ, et al. Physician and patient perceptions in COPD: The COPD Resource Network Needs Assessment survey. American Journal of Medicine. 2005; 118(12):1415
  2. Cabana MD, Slish KK, Evans D, et al. Impact of physician asthma care education on patient outcomes. Pediatrics. 2006; 117(6):2149-2157.
  3. Denlinger LC, Sorkness CA, Chinchilli VM, Lemanske RF. Guideline- defining asthma clinical trials of the National Heart, Lung, and Blood Institute’s Asthma Clinical Research Network. Journal of Allergy & Clinical Immunology. 2007; 119(1): 3-11.
  4. Department of Health & Human Services. Statement by HHS secretary Tommy G. Thompson: Regarding World Asthma Day. May 7, 2002. Accessed October 2010
  5. Expert Panel Report 3 (EPR-3): Guidelines for the diagnosis and management of asthma- Summary report 2007. Journal of Allergy & Clinical Immunology. 2007; 120 (5 Suppl):S94-138
  6. Fuhlbrigge AL. Asthma severity and asthma control: symptoms, pulmonary function, and inflammatory markers. Current Opinion in Pulmonary Medicine. 2004; 10:1-6.
  7. Klomp H, Lawson JA, Cockcroft DW, et al. Examining asthma quality of care using a population-based approach. Cmaj. 2008; 178(8):1013-1021.
  8. Lagerlov P, Loeb M, Andrew M, Hjortdahl P. Improving doctor’s prescribing behavior through reflection on guidelines and prescription feedback: a randomized controlled study. Quality Health Care. 2009; 9(3):159-165.
  9. LeRoy MG. Classifying Asthma. CHEST. 2006; 130: 13s-20s.
  10. Loughheed MD. Variability in Asthma: symptom perception, care, and outcomes. Canadian Journal of Physiologic Pharmacology. 2007; 85(1):149-154.
  11. Moore PL. Practice Management and chronic obstructive pulmonary disease in primary care. American Journal of Medicine. 2007; 120 (8 Suppl 1): S23-S27.
  12. Mortimer KM, Fallot A, BalmesJR, Tager IB. Evaluating the use of a portable spirometer in a study of pediatric asthma. CHEST. 2003; 123 (6): 1899-1907
  13. National Committee for Quality Assurance. The State of Healthcare Quality. Washington DC: National Committee for Quality Assurance; 2007.
  14. National Heart Lung and Blood Institute. Morbidity & Mortality: 2007 Chart book on Cardiovascular, Lung, and Blood Diseases. Accessed October 2010
  15. NCHS FASTAS for Asthma

Accessed October 2010.

  1. Outcomes Inc. Final Report: Optimizing Asthma Control for the Primary Care Physician: Three Part Newsletter series: National Jewish Medical & Research Center; June 30, 2008.
  2. Schreck DM, Williams DM. Case studies illustrating the implementation of treatment strategies for acute & chronic asthma. American Journal of Health System Pharmacists. 2006; 63 (10 Suppl 3):S22-26.
  3. Yawn BP, Enright PL, Lemanske RF, et al. Spirometry can be done in family physicians’ offices and alters clinical decisions in management of asthma and COPD. CHEST. 2007; 132(4): 1162-1168
  4. Zanconato S, Meneghelli G, Braga R, Zacchello F, Baraldi E. Office Spirometry in primary care pediatrics: A pilot study. Pediatrics. 2005; 116 (6): e792-e797.

Needs Assessment for COPD

Chronic Obstructive Pulmonary disease (COPD) affected 12.1 million Americans in 2008 (American Lung Association, Trends in COPD 2010). COPD is clinically defined by the chronic limitation in airflow that is not fully reversible with a wide range of pathological changes in the lung including inflammation in the proximal and distal airways. ( 2009) Resultant changes in the lung composition can produce systemic effects and comorbid conditions. The level of airway obstruction is determined by a post bronchodilator FEV1/ FVC with < 0.7 being the standard for diagnosis. COPD is the fourth leading cause of death in the United States, accounting for approximately 126,000 deaths in 2005 (

The National Institutes of Health estimates that there are 12 million Americans diagnosed, with an additional 12 million who are either symptomatic or in the process of developing COPD (National Institutes of Health, 2009). The economic burden is substantial accounting for 726,000 hospitalizations, 1.5 million emergency department visits, and another 8 million hospital outpatient treatments in the primary care setting (Centers for Disease Control & Prevention, 2010). The projected economic costs, both direct and indirect for 2010 are thought to be $49.9 billion ( 2010). The importance of early detection and aggressive treatment is crucial, yet COPD continues to be under-diagnosed and under-treated, which causes unnecessary suffering and rising healthcare costs (GOLD, 2009).

A study done in conjunction with the National Committee for Quality Assurance (NCQA), demonstrated that only 32% of patients who are diagnosed with COPD have had it confirmed with spirometry (Han, 2007). Spirometry for COPD evaluation may be severely underutilized, especially by primary care physicians. Spirometry can assist with the differential diagnosis between asthma and COPD (Yawn, 2007). Spirometry is useful for monitoring disease progression, as well as determining the patients current GOLD stage which can dictate how best to implement evidence-based therapy (

Effective therapeutic regimens have been developed, but are not necessarily known / utilized by practicing clinicians (Murray, 2010). Guidelines provide direction in the screening, diagnosis, treatment, and management of COPD.

According to the Global Strategy for the Diagnosis, Management, and Prevention of COPD (2009), the goals of COPD management include:

  • Relieve symptoms
  • Prevent disease progression
  • Improve exercise tolerance
  • Improve health status
  • Prevent & treat complications
  • Prevent & treat exacerbations
  • Reduce mortality

Both pharmacologic and non-pharmacologic treatment options can make a difference in the quality of life of COPD patients. Therapy can include; smoking cessation support, pulmonary rehabilitation, long acting bronchodilators, inhaled corticosteroids, and the use of oxygen (Gold, 2009).

The Quality Gap to be addressed:

The needs assessment implies that the following gaps still remain for the majority of healthcare providers in caring for COPD patients.

  • Practicing clinicians often fail to recognize and treat COPD in its early stages
  • Spirometry requires a skilled operator, as well as a cooperative patient to obtain valid results (Celli, 2010). Physicians must also be able to interpret the findings to obtain a correct diagnosis.
  • Spirometry should be used routinely to monitor the progression of COPD, so that appropriate treatment changes can be made ((Yawn, 2007).
  • Lack of patient education / understanding of FEV levels, proper inhaler use, as well as adherence to treatment plans can impact overall morbidity and quality of life
  • Stabilizing the disease as well as managing exacerbations is an important goal in COPD

Without proper testing, both under-diagnosis and misdiagnosis may occur, which can lead to improper therapies being prescribed and a worsening of medical conditions in these patients (Han, 2007).

Cited references

  1. Global Strategy for the Diagnosis, Management Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2009. Available at: Accessed November 11, 2010
  2. National Institutes of Health. Available at: Accessed November 11, 2010
  3. Murray, S., Cytryn, K., Barrett, T., Meinzer, R. Outcomes Evaluation of a Skill-Based Workshop Targeting the Use of Spirometry in Chronic Obstructive Pulmonary disease. CE Measure. 2010; 4:50-57.
  4. Centers for Disease Control & Prevention. Facts about COPD, available at: Accessed November 12, 2010.
  5. Han, MK., Mardon, R., et al. Spirometry Utilization for COPD: How do we measure up? CHEST. 2007; 132(2):403-409.
  6. Yawn, B., Enright, P., Lemanske, R., Israel, E., et al. Spirometry can be done in Family Physicians’ Offices and Alters the Management of Asthma & COPD. CHEST.2007; 132; 1162-1168.
  7. Celli, B., & Halbert, R. Point: Should we abandon FEV1/FVC <0.70 to Detect Airway Obstruction? No CHEST.2010:138:1037-1040.
  8. US Direct & Indirect Costs of COPD. Adapted from the American Lung Association, 2010. Accessed; November 16, 2010.
  9. 9. American Lung Association. Trends in COPD: Morbidity & Mortality, epidemiology & statistics unit, Research & Program Services. Accessed on November 12, 2010. Available at:

Program Requirements:

The Program must be accredited and fully compliant with the criteria and/or standards of commercial support for ACCME, AAFP, AOA, ACPE, ANCC, AANP, or NCCPA. Furthermore, the program will be educational and non-promotional in nature and will be planned, designed and implemented in accordance with the U.S. Food and Drug Administration’s Guidance on Industry-Supported Scientific and Educational Activities ("Policy Statement").

The Policy Statement and the ACCME Standards require, among other things, that (i) Institution conduct the Program independently and without control or influence by AstraZeneca over the Program's planning, content (including the selection of speakers or moderators), or execution; (ii) the Program be free of commercial bias for or against any product; (iii) Institution make meaningful disclosure of AstraZeneca support of the Program and any prior relationship between Institution and AstraZeneca, and the relationship, if any, between AstraZeneca and the speakers selected by Institution; and (iv) AstraZeneca not engage in, and Institution not permit any other sponsor to engage in, promotional activities in or near the Program room or advertise its products in any materials disseminated as part of the Program.

In addition, Institution is required by the Policy Statement and the ACCME Standards to ensure that any product discussions at the Program be accurate, objective, balanced and scientifically rigorous. This includes a balanced discussion of each product and of treatment alternatives, that limitations on data be disclosed, that unapproved uses be identified as such, and that for live presentations there be opportunities for questioning or debate.

RMEINDER - Submission Instructions:

Call for Grants Application Title: “CGA RESP 1102 – Program Title…”

Submission Instructions:

•Your title must begin with Call for Grants Application (CGA) ID number.

•Refer to Grant Submission Instructions for further information on submitting your formal grant application.