AsthmaNCT00005537
Genetics of Airway Responsiveness and Lung Function
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1997to Jun 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.
Read the detailed description
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.
- Medical subject headings
- Asthma, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1997
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Xiping Xu, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005537
- Sponsor's protocol ID
- 5071
- Other IDs
- R01HL056371
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Hu FB, Wang B, Chen C, Jin Y, Yang J, Stampfer MJ, Xu X. Body mass index and cardiovascular risk factors in a rural Chinese population. Am J Epidemiol. 2000 Jan 1;151(1):88-97. doi: 10.1093/oxfordjournals.aje.a010127.
PubMed 10625178Xu X, Yang J, Chen C, Wang B, Jin Y, Fang Z, Wang X, Weiss ST. Familial aggregation of pulmonary function in a rural Chinese community. Am J Respir Crit Care Med. 1999 Dec;160(6):1928-33. doi: 10.1164/ajrccm.160.6.9902013.
PubMed 10588608Wang X, Wang B, Chen C, Yang J, Fang Z, Zuckerman B, Xu X. Familial aggregation of blood pressure in a rural Chinese community. Am J Epidemiol. 1999 Mar 1;149(5):412-20. doi: 10.1093/oxfordjournals.aje.a009828.
PubMed 10067900Xu X, Niu T, Chen C, Wang B, Jin Y, Yang J, Weiss ST. Association of airway responsiveness with asthma and persistent wheeze in a Chinese population. Chest. 2001 Mar;119(3):691-700. doi: 10.1378/chest.119.3.691.
PubMed 11243944Betensky RA, Hudson JI, Jones CA, Hu F, Wang B, Chen C, Xu X. A computationally simple test of homogeneity of odds ratios for twin data. Genet Epidemiol. 2001 Feb;20(2):228-38. doi: 10.1002/1098-2272(200102)20:23.0.CO;2-4.
PubMed 11180448Niu T, Rogus JJ, Chen C, Wang B, Yang J, Fang Z, Weiss ST, Xu X. Familial aggregation of bronchodilator response: a community-based study. Am J Respir Crit Care Med. 2000 Nov;162(5):1833-7. doi: 10.1164/ajrccm.162.5.9908127.
PubMed 11069822Xu X, Fang Z, Wang B, Chen C, Guang W, Jin Y, Yang J, Lewitzky S, Aelony A, Parker A, Meyer J, Weiss ST, Xu X. A genomewide search for quantitative-trait loci underlying asthma. Am J Hum Genet. 2001 Dec;69(6):1271-7. doi: 10.1086/324650. Epub 2001 Oct 22.
PubMed 11673820Venners SA, Wang X, Chen C, Wang B, Ni J, Jin Y, Yang J, Fang Z, Weiss ST, Xu X. Exposure-response relationship between paternal smoking and children's pulmonary function. Am J Respir Crit Care Med. 2001 Sep 15;164(6):973-6. doi: 10.1164/ajrccm.164.6.2009063.
PubMed 11587981Wang Z, Chen C, Niu T, Wu D, Yang J, Wang B, Fang Z, Yandava CN, Drazen JM, Weiss ST, Xu X. Association of asthma with beta(2)-adrenergic receptor gene polymorphism and cigarette smoking. Am J Respir Crit Care Med. 2001 May;163(6):1404-9. doi: 10.1164/ajrccm.163.6.2001101.
PubMed 11371409
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Airway Responsiveness and Lung Function
- ClinicalTrials.gov ID
- NCT00005537
- Acronym / sponsor ID
- 5071
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1997
- Study completion
- Jun 2002 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.
Detailed description
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 10625178Hu FB, Wang B, Chen C, Jin Y, Yang J, Stampfer MJ, Xu X. Body mass index and cardiovascular risk factors in a rural Chinese population. Am J Epidemiol. 2000 Jan 1;151(1):88-97. doi: 10.1093/oxfordjournals.aje.a010127.
- Background: PubMed 10588608Xu X, Yang J, Chen C, Wang B, Jin Y, Fang Z, Wang X, Weiss ST. Familial aggregation of pulmonary function in a rural Chinese community. Am J Respir Crit Care Med. 1999 Dec;160(6):1928-33. doi: 10.1164/ajrccm.160.6.9902013.
- Background: PubMed 10067900Wang X, Wang B, Chen C, Yang J, Fang Z, Zuckerman B, Xu X. Familial aggregation of blood pressure in a rural Chinese community. Am J Epidemiol. 1999 Mar 1;149(5):412-20. doi: 10.1093/oxfordjournals.aje.a009828.
- Background: PubMed 11243944Xu X, Niu T, Chen C, Wang B, Jin Y, Yang J, Weiss ST. Association of airway responsiveness with asthma and persistent wheeze in a Chinese population. Chest. 2001 Mar;119(3):691-700. doi: 10.1378/chest.119.3.691.
- Background: PubMed 11180448Betensky RA, Hudson JI, Jones CA, Hu F, Wang B, Chen C, Xu X. A computationally simple test of homogeneity of odds ratios for twin data. Genet Epidemiol. 2001 Feb;20(2):228-38. doi: 10.1002/1098-2272(200102)20:23.0.CO;2-4.
- Background: PubMed 11069822Niu T, Rogus JJ, Chen C, Wang B, Yang J, Fang Z, Weiss ST, Xu X. Familial aggregation of bronchodilator response: a community-based study. Am J Respir Crit Care Med. 2000 Nov;162(5):1833-7. doi: 10.1164/ajrccm.162.5.9908127.
- Background: PubMed 11673820Xu X, Fang Z, Wang B, Chen C, Guang W, Jin Y, Yang J, Lewitzky S, Aelony A, Parker A, Meyer J, Weiss ST, Xu X. A genomewide search for quantitative-trait loci underlying asthma. Am J Hum Genet. 2001 Dec;69(6):1271-7. doi: 10.1086/324650. Epub 2001 Oct 22.
- Background: PubMed 11587981Venners SA, Wang X, Chen C, Wang B, Ni J, Jin Y, Yang J, Fang Z, Weiss ST, Xu X. Exposure-response relationship between paternal smoking and children's pulmonary function. Am J Respir Crit Care Med. 2001 Sep 15;164(6):973-6. doi: 10.1164/ajrccm.164.6.2009063.
- Background: PubMed 11371409Wang Z, Chen C, Niu T, Wu D, Yang J, Wang B, Fang Z, Yandava CN, Drazen JM, Weiss ST, Xu X. Association of asthma with beta(2)-adrenergic receptor gene polymorphism and cigarette smoking. Am J Respir Crit Care Med. 2001 May;163(6):1404-9. doi: 10.1164/ajrccm.163.6.2001101.
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiping Xu
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005537, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.