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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