Asthma Clinical Trial
To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.
DESIGN NARRATIVE:
Airway responsiveness and lung function, endpoints with a strong genetic basis, are central
to the obstructive airway diseases (asthma and COPD). In contrast, the dissection of the
underlying genes requires unique sample resources, accurate and comprehensive phenotyping,
and an efficient study design. To address to this three-pronged challenge, a genomic screen
brought together a large, homogenous, mostly untreated sample from Anhui, China, a wealth of
expertise in asthma phenotypes, and a potent study design based on extreme discordant sib
pairs.
Since this approach utilized an extant asthmatic family population, no support for data
collection was required. The primary focus of the study was two intermediate phenotypes
related to asthma and COPD: airway responsiveness (characterized by increased responsiveness
to histamine methacholine or other nonspecific agonists and measured by the slope of the
dose response relationship) and forced expiratory volume in 1 second (FEV1). Since both
traits are continuous, the appropriate study design considered only siblings with extremely
discordant phenotypes. For many studies, this strategy was not feasible due to the thousands
of families that must be phenotyped to identify a sample of such siblings. The plan was to
utilize the organization of a well-established network in China to collect 150 extreme
discordant sib pairs of each intermediate phenotype. For airway responsiveness, the
estimated power from this sample, equivalent to roughly 600 concordant sib pairs, was
intended to surpass the power of all existing studies, including the U.S. Collaborative
Study on the Genetics of Asthma. Further, with similar power, this was the first study to
test for linkage to FEV1. Moreover, to further augment power, potential phenotypic
heterogeneity was reduced by stratifying the analyses by total and specific serum IgE
levels, skin test reactivity, peripheral blood eosinophilia, respiratory symptoms, age,
gender, bronchodilator response, and cigarette smoking.
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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N/A
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