Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091767
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2004-09-16
Brief Title:
Genetic Studies in Difficult to Treat Asthma TENOR
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate genetic factors that affect asthma severity
Detailed Description:
BACKGROUND
The TENOR The Epidemiology and Natural History of Asthma Outcomes and Treatment Regimens study is an ongoing three-year multi-center observational cohort study of 4756 severe or difficult-to-treat patients with asthma aged 6 or older Of this group of asthmatics 446 meet the National Heart Lung and Blood Institute National Asthma Education and Prevention Program guidelines for severe persistent asthma 275 for moderate persistent asthma and 278 for mild persistent asthma All subjects were evaluated initially with comprehensive questionnaires and laboratory testing and are then seen every 6 months during the remaining 3 years of the study Phenotypic information collected includes information on asthma exacerbations medication use urgent care visits quality of life pulmonary function tests spirometry with reversibility total serum IgE levels and history of allergies If accessed now before the termination of the TENOR study this population represents one of the largest populations of phenotypically characterized difficult-to-treat and severe asthmatics potentially available for genomic and pharmacogenetic studies TENOR will finish at the end of 2004 thus there is a very short time window in which to obtain DNA samples for genetic studies before the termination of the study Isolation and storage of DNA from this well characterized longitudinal population will serve as a resource not only for the studies in this grant but also for future genomics and pharmacogenetic studies in asthma
DESIGN NARRATIVE
The study investigates genetic factors that affect asthma severity in the TENOR subjects The study tests the hypothesis that factors which produce difficult-to-treat and severe asthma are produced by altered inflammatory responses that are related at least in part to sequence variants polymorphisms in genes that regulate inflammation allergic responsiveness andor affect structural components in the airways The study also tests the hypothesis that some patients develop more severe asthma because of genetic differences that modulate their responses to pharmacologic agents To test these hypotheses the following specific aims will be carried out 1 Obtain DNA samples from at least 4000 asthmatics currently enrolled in the ongoing TENOR study 2 Determine whether sequence variants polymorphisms in genes that regulate inflammation cellular responses andor tissue injury and repair are more frequently associated with asthma severity using the baseline data 3 Determine the importance of genetic polymorphisms in genes that may be important in IgE regulation in this population of difficult-to-treat patients with asthma 4 Evaluate pharmacogenetic relationships between polymorphisms in the a2 adrenergic receptor a2AR in those subjects on long-acting beta-2-agonists to determine the effect on asthma severity 5 Evaluate pharmacologic mechanisms by investigating whether polymorphisms in genes that regulate responses to asthma therapy are more frequent in severe disease
The TENOR The Epidemiology and Natural History of Asthma Outcomes and Treatment Regimens study is an ongoing three-year multi-center observational cohort study of 4756 severe or difficult-to-treat patients with asthma aged 6 or older Of this group of asthmatics 446 meet the National Heart Lung and Blood Institute National Asthma Education and Prevention Program guidelines for severe persistent asthma 275 for moderate persistent asthma and 278 for mild persistent asthma All subjects were evaluated initially with comprehensive questionnaires and laboratory testing and are then seen every 6 months during the remaining 3 years of the study Phenotypic information collected includes information on asthma exacerbations medication use urgent care visits quality of life pulmonary function tests spirometry with reversibility total serum IgE levels and history of allergies If accessed now before the termination of the TENOR study this population represents one of the largest populations of phenotypically characterized difficult-to-treat and severe asthmatics potentially available for genomic and pharmacogenetic studies TENOR will finish at the end of 2004 thus there is a very short time window in which to obtain DNA samples for genetic studies before the termination of the study Isolation and storage of DNA from this well characterized longitudinal population will serve as a resource not only for the studies in this grant but also for future genomics and pharmacogenetic studies in asthma
DESIGN NARRATIVE
The study investigates genetic factors that affect asthma severity in the TENOR subjects The study tests the hypothesis that factors which produce difficult-to-treat and severe asthma are produced by altered inflammatory responses that are related at least in part to sequence variants polymorphisms in genes that regulate inflammation allergic responsiveness andor affect structural components in the airways The study also tests the hypothesis that some patients develop more severe asthma because of genetic differences that modulate their responses to pharmacologic agents To test these hypotheses the following specific aims will be carried out 1 Obtain DNA samples from at least 4000 asthmatics currently enrolled in the ongoing TENOR study 2 Determine whether sequence variants polymorphisms in genes that regulate inflammation cellular responses andor tissue injury and repair are more frequently associated with asthma severity using the baseline data 3 Determine the importance of genetic polymorphisms in genes that may be important in IgE regulation in this population of difficult-to-treat patients with asthma 4 Evaluate pharmacogenetic relationships between polymorphisms in the a2 adrenergic receptor a2AR in those subjects on long-acting beta-2-agonists to determine the effect on asthma severity 5 Evaluate pharmacologic mechanisms by investigating whether polymorphisms in genes that regulate responses to asthma therapy are more frequent in severe disease
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL076285-03 | NIH | None | httpsreporternihgovquickSearchR01HL076285-03 |