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Home > "G" Clinical Trials Conditions > Genetics of Airway Responsiveness and Lung Function  Genetics of Airway Responsiveness and Lung Function
Genetics of Airway Responsiveness and Lung Function
For Condition: Asthma,Lung Diseases, Obstructive,Chronic Obstructive Pulmonary Disease
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.
Details: 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 will bring 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 utilizes an extant asthmatic family population, no support for data collection is required. The primary focus of the study is 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 is one that considers only siblings with extremely discordant phenotypes. For many studies, this strategy is not feasible due to the thousands of families that must be phenotyped to identify a sample of such siblings. The plan is 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, is 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 will be the first study to test for linkage to FEV1. Moreover, to further augment power, potential phenotypic heterogeneity will be 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
XipingXu, , Brigham and Women's Hospital
Additional Information:
Study ID Numbers: 5071;
Study Start Date: July 1997
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005537
Other Lung Diseases, Obstructive Studies:
1. Clinical Study of Intermittent Positive Pressure Breathing (IPPB)
2. Genetics of Airway Responsiveness and Lung Function
3. Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals
4. Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)
5. Clinical Trial of Acid Reflux Therapy in Asthma
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