Chronic Obstructive Pulmonary Disease Clinical Trial
To examine the relationship of specific dietary factors to risk of chronic obstructive pulmonary disease.
BACKGROUND:
Although tobacco smoking is the major environmental risk factor for COPD, only a minority of
smokers develops this condition, and it appears that genetic and other environmental factors
are important in determining risk. There has been growing interest in the hypothesis that
dietary factors modify COPD risk, possibly by protecting against oxidant injury. Available
data addressing this hypothesis have a variety of methodological limitations that preclude
any firm conclusions. The study was the first to address this hypothesis using data from the
Nurses' Health Study, a large, prospective cohort study with detailed dietary assessments
and a follow-up interval of sufficient duration to examine incident COPD.
DESIGN NARRATIVE:
The study examined the relationship between dietary factors and chronic obstructive
pulmonary disease (COPD) among participants in the Nurses' Health Study, an ongoing
prospective cohort study of 121,700 women, ages 39-64 in 1985. This cohort had been followed
by means of biennial questionnaires which inquired about a variety of topics, including
dietary intake (using a validated semi-quantitative food frequency questionnaire) and
physician diagnosis of COPD. In 1998, all participants with a history of COPD were sent a
supplementary questionnaire regarding specifics of COPD diagnosis and related topics. The
study examined the relation of dietary factors to risk of newly-diagnosed COPD during
1985-1998. During this time period, there were approximately 2,100 cases of "confirmed" COPD
(i.e., physician diagnosis and pulmonary function tests [PFTs] at time of diagnosis or
abnormal FEV-I in past year) and "probable" COPD (i.e., physician diagnosis and recent
respiratory symptoms, but PFTs not known). Preliminary data supported the validity of these
case definitions, and this was examined further by reviewing 600 medical records. Likewise,
potential under-diagnosis was examined in a random sample of past and current smokers who
had never reported COPD or asthma. The specific dietary hypotheses were that high intakes of
antioxidants (e.g., vitamin C, vitamin E, and carotenoids), magnesium, potassium, and n-3
polyunsaturated fatty acids (e.g., fish oils) decreased risk of COPD, whereas high intakes
of specific fatty acids (e.g., linoieic acid) increased risk. The cohort size and 13-year
follow-up provided >90 percent power to detect a trend across quintiles of dietary intake.
In 1998, among approximately 2,400 prevalent cases with diet data, study investigators
addressed a secondary aim: to determine the relation of dietary factors to COPD severity
during 1998-2000. COPD severity was assessed by self-report of current medications, recent
symptoms, activity limitations, and health care utilization (e.g., emergency room or urgent
office visits for COPD exacerbations). The rising prevalence of COPD, particularly among
women, along with its high societal cost, makes COPD prevention an important public health
goal.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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