Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501926
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2020-07-30
Brief Title:
Genomics and Metagenomics of Asthma Severity
Sponsor:
Maria Pino-Yanes
Organization:
University of La Laguna
Study Overview
Official Title:
Genomics and Metagenomics of Asthma Severity
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
GEMAS
Brief Summary:
The Genomics and Metagenomics of Asthma Severity GEMAS study aims to assess the role of genomics the microbiome and the interaction between them in the development of asthma exacerbations in European patients with asthma
Detailed Description:
Asthma is a chronic inflammatory disease of the airways characterized by reversible airflow obstruction and a bronchial hyperreactivity in response to a variety of stimuli In most patients the onset of asthma symptoms may be controlled However many of them may manifest asthma attacks or crises of breathing called exacerbations which occur with breathing problems wheezing coughing or tightness of chest and may threaten their life Such exacerbations are caused by a combination of environmental and genetic factors However since studies so far have been limited a reduced number of genes associated with the predisposition to these complications have been identified In addition some studies have used next-generation DNA sequencing techniques to characterize the microbiome ie microbial community of the airways finding changes related to asthma The main hypothesis of the Genomics and Metagenomics of Asthma Severity GEMAS study is that exacerbations of asthma are caused by a combination of the intrinsic genetic factors of the individual changes in the respiratory microbiome and the interaction between both factors The objectives of this project are 1 to identify genetic variants that are associated with asthma exacerbations 2 to examine the changes occurring in the microbial communities of the oral cavity and respiratory tract in individuals with exacerbations 3 to analyze the association of the host genetic variants and the microbiome changes related to exacerbations
A total of 300 Spanish subjects with asthma with and without a history of asthma exacerbations in the past 12 months will be recruited Saliva nasal and pharyngeal samples will be collected to study the oral cavity and the upper respiratory tract microbiome through next-generation sequencing technologies Sequencing of the 16S ribosomal RNA 16S rRNA gene will allow to characterize the bacterial diversity and abundance as well as to infer the functionality of the microbiome in each sample These parameters will be used to establish correlations between the microbiome and the presence of asthma exacerbations Finally the association between the genetic variation associated with exacerbations in genomic studies and the measurements of abundance diversity and functions related to exacerbations will be jointly examined
A total of 300 Spanish subjects with asthma with and without a history of asthma exacerbations in the past 12 months will be recruited Saliva nasal and pharyngeal samples will be collected to study the oral cavity and the upper respiratory tract microbiome through next-generation sequencing technologies Sequencing of the 16S ribosomal RNA 16S rRNA gene will allow to characterize the bacterial diversity and abundance as well as to infer the functionality of the microbiome in each sample These parameters will be used to establish correlations between the microbiome and the presence of asthma exacerbations Finally the association between the genetic variation associated with exacerbations in genomic studies and the measurements of abundance diversity and functions related to exacerbations will be jointly examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None