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New Research Shows Many Patients with Persistent Cough and Sputum Actually had Airway Obstruction Consistent with COPD

- More than one quarter (26%) of primary care patients 40 years of age and older with a smoking history and symptoms of chronic bronchitis had airflow

obstruction consistent with a diagnosis of COPD - Percentages were greater with increasing patient age and smoking history

PHILADELPHIA, Oct. 28 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced findings from a cross-sectional study which showed that 26 percent of primary care patients 40 years of age and older with a history of smoking and symptoms of chronic bronchitis actually had airway obstruction consistent with chronic obstructive pulmonary disease (COPD) - yet were not diagnosed with the disease.

The data also show that as age and smoking history increased the percent of patients with COPD increased - roughly half (49%) of the patients over 60 years of age with more than a 20-pack year history of smoking had an FEV(1) (forced expiratory flow in one second)/FVC (forced vital capacity) ratio consistent with COPD; 40 percent of patients over 50 years of age who had more than a 30-pack year history of smoking also had FEV(1)/FVC consistent with COPD. For the group over 70 years of age with more than a 40-pack year history, the percent increased to 72.

Overall, only 4 percent of patients in this study had been diagnosed with COPD by their clinician. These data were presented in Philadelphia at CHEST 2008, the annual meeting of the American College of Chest Physicians.

"Understanding the patients who are at greatest risk for having undiagnosed COPD should help improve disease recognition, diagnosis and management," said Barbara Yawn, M.D., lead author and director of research at the Olmsted Medical Center, Rochester, MN. "Spirometry should be considered in anyone with symptoms and a 10 or greater pack-year smoking history - which is how we will improve recognition of COPD."

In the study, pre- and post-bronchodilatory spirometry was performed on all patients. Albuterol was self-administered for determination of post- bronchodilator FEV(1)/FVC ratio, post-albuterol FEV(1)% of predicted normal and FEV(1) reversibility. All patients had self-reported symptoms of chronic bronchitis and were current or previous cigarette smokers with a history of cigarette smoking of > or = 10 pack-years. COPD was defined as a post- bronchodilator FEV(1)/FVC < or = 0.7.

COPD is characterized by a progressive airflow limitation that is not fully reversible and is associated with an abnormal inflammatory response of the lungs, primarily caused by smoking. The range of conditions described by COPD, which include chronic bronchitis and emphysema, has led to confusion about disease terminology and difficulty with diagnosis especially in the primary care setting. Despite the availability of effective medicines to help manage the disease, many patients with COPD remain undiagnosed and under- treated. This study aimed to characterize airway obstruction, patient characteristics, and patient and provider awareness and understanding of COPD in primary care patients with symptoms of chronic bronchitis.

About the Study

This was a multi-center, cross-sectional study of more than 1,200 subjects 40 years of age and older with a minimum 10 pack-year smoking history and symptoms of chronic bronchitis recruited from primary care centers. There was no treatment intervention in the study. Each study subject completed a single visit encompassing all study procedures, which included two questionnaires completed by each study subject. One questionnaire was a compilation of the medical research council (MRC) dyspnea scale, the 12-item Short Form Health Survey (SF-12, version 2), a modified American Thoracic Society (ATS) respiratory questionnaire, and additional questions about disease and smoking history, work and non-work activities missed due to breathing problems. The other questionnaire, The Lung Function Questionnaire (LFQ), was comprised of seven questions related to respiratory symptoms, smoking history and age.

About the Lung Function Questionnaire

Data was also presented at CHEST 2008 on the development of the Lung Function Questionnaire (LFQ), a patient screening tool to help identify patients at risk for airflow obstruction who are candidates for spirometry and to help address undiagnosed COPD issues.

The LFQ is being developed in 3 phases: 1) Empirical phase: candidate questionnaire items were identified and their accuracy evaluated using data from NHANES III; 2) Qualitative phase: questions identified in phase 1 were evaluated for clarity by patients/clinicians; 3) Quantitative phase: ongoing validation study of the LFQ in screening for airway obstruction. The LFQ contained age, wheeze, dyspnea, smoking and phlegm as questions being predictive of airflow obstruction. LFQ demonstrates moderate screening accuracy both in a chronic bronchitis population as well as in a general population in NHANES. Additional validation studies are underway to further evaluate LFQ in a general population.

Background on COPD

An estimated 24 million Americans suffer from COPD, which is the fourth leading cause of death in the United States. COPD is a progressive, life- threatening lung disease that includes chronic bronchitis and emphysema. It is characterized by airflow obstruction, a limitation in lung function that makes it difficult to breathe. Many patients have components of both chronic bronchitis and emphysema. Symptoms of COPD include chronic cough, chest tightness, shortness of breath, an increased effort to breathe and increased mucus production. Typically, patients with COPD develop shortness of breath during exertion, which continues and gradually worsens. Most patients also develop a productive, chronic cough. Over time, many patients suffer from shortness of breath so severe that it interferes with their most basic daily activities including sleeping, talking, and even dressing. The gradual loss of lung function, coupled with other symptoms and exacerbations, often lead to hospitalization and can be disabling and life-threatening.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.

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SOURCE GlaxoSmithKline
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