Genomics and Metagenomics of Asthma Severity (GEMAS)
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ClinicalTrials.gov Identifier: NCT04501926 |
Recruitment Status : Unknown
Verified May 2022 by Maria Pino-Yanes, University of La Laguna.
Recruitment status was: Recruiting
First Posted : August 6, 2020
Last Update Posted : May 17, 2022
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Condition or disease |
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Asthma Asthma Attack |
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 (i.e., 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.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Case-Control |
Time Perspective: | Retrospective |
Official Title: | Genomics and Metagenomics of Asthma Severity |
Actual Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Group/Cohort |
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Controls
Asthma patients who did not report asthma exacerbations in the 12 months prior recruitment, defined by one of the following events because of asthma: oral corticosteroids use, emergency room visits, and/or hospitalizations.
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Cases
Asthma patients that reported asthma exacerbations in the 12 months prior recruitment, defined by one of the following events because of asthma: oral corticosteroids use, emergency room visits, and/or hospitalizations.
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- Severe asthma exacerbations [ Time Frame: 1 year ]Defined by one of the following events because of asthma during the past year, the past 6 months, and the past week: oral corticosteroids use, emergency room visit, and/or hospitalizations
- Asthma control [ Time Frame: 1 week ]Asthma control questionnaire (ACQ) score
- Asthma severity [ Time Frame: 1 year ]Category of severity defined by treatment step according to GINA 2020 at recruitment
- Lung function measurement: forced expiratory volume in the first second (FEV1) [ Time Frame: 3 months ]Baseline and post-bronchodilator measurements of the forced expiratory volume in the first second (FEV1) measured in liters
- Lung function measurement: forced vital capacity (FVC) [ Time Frame: 3 months ]Baseline and post-bronchodilator measurements of the forced vital capacity (FVC) measured in liters
- Lung function measurement: FEV1/FVC ratio [ Time Frame: 3 months ]The ratio of FEV1/FVC measurements
- Atopy testing [ Time Frame: 1 year ]Atopy status evaluated by skin prick tests and/or specific immunoglobulin E (IgE) levels assessing the most common aeroallergens of each recruiting center
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 8 Years to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male or female aged older or equal than 8 years and younger or equal than 85 years
- Physician diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
- Treated on GINA step 1-5
Exclusion Criteria:
- One or more grandparents of non-European origin
- Pregnancy
- Coexistence of other chronic pulmonary disorders including cystic fibrosis, chronic obstructive pulmonary disease (emphysema or chronic bronchitis), or congenital disorders of the lungs or airways
- Known family relatedness (first or second degree) with another participant already included in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501926
Contact: Maria Pino-Yanes, Ph.D. | +34 922 316 502 ext 6343 | mdelpino@ull.edu.es | |
Contact: Fabian Lorenzo-Diaz, Ph.D. | +34 922 316 502 ext 8350 | florenzo@ull.edu.es |
Spain | |
University of La Laguna | Active, not recruiting |
San Cristobal de la Laguna, Santa Cruz De Tenerife, Spain, 38200 | |
Hospital Doctor Jose Molina Orosa | Recruiting |
Arrecife, Spain | |
Contact: Berta Roman-Bernal, MD | |
Hospital General de La Palma | Recruiting |
Breña Alta, Spain | |
Contact: Jose M Hernandez-Perez, MD, Ph.D. | |
Hospital Universitario de Canarias | Recruiting |
San Cristobal de la Laguna, Spain | |
Contact: Ruperto Gonzalez-Perez, MD, Ph.D. | |
Hospital Universitario Donostia | Recruiting |
San Sebastián, Spain | |
Contact: Olaia Sardon, MD, Ph.D. | |
Hospital Universitario Nuestra Señora de Candelaria | Recruiting |
Santa Cruz De Tenerife, Spain | |
Contact: Jose M Hernandez-Perez, MD, Ph.D. |
Responsible Party: | Maria Pino-Yanes, Ramon y Cajal Fellow and Lecturer, University of La Laguna |
ClinicalTrials.gov Identifier: | NCT04501926 |
Other Study ID Numbers: |
PI-29/17 |
First Posted: | August 6, 2020 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Genome-Wide Association Study Microbiome, Human Asthma Epigenomics Transcriptomics |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |