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GlaxoSmithKline (NYSE:
GSK) 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.
GlaxoSmithKline
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