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Genomics and Metagenomics of Asthma Severity (GEMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04501926
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
University of La Laguna
Spanish Ministry of Science, Innovation, and Universities
Consorcio Centro de Investigación Biomédica en Red, M.P.
University Hospital of the Nuestra Señora de Candelaria
Hospital Universitario de Canarias
Hospital General de La Palma
Hospital Universitario Donostia
Hospital Doctor Jose Molina Orosa
Information provided by (Responsible Party):
Maria Pino-Yanes, University of La Laguna

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.

Condition or disease
Asthma Asthma Attack

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 (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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Asthma control [ Time Frame: 1 week ]
    Asthma control questionnaire (ACQ) score

  2. Asthma severity [ Time Frame: 1 year ]
    Category of severity defined by treatment step according to GINA 2020 at recruitment

  3. 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

  4. 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

  5. Lung function measurement: FEV1/FVC ratio [ Time Frame: 3 months ]
    The ratio of FEV1/FVC measurements

  6. 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
Blood samples are drown in EDTA tubes and PAXGene tubes for human DNA and RNA extraction, respectively. For the human microbiome study, saliva samples and nasal and pharyngeal swaps are collected.


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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
Study Population
Patients are recruited from the allergy and/or pulmonary medicine units from hospitals located in the Canary Islands, Spain (Hospital Universitario de Canarias, Hospital Universitario Nuestra Señora de Candelaria, Hospital General de La Palma, and Hospital Doctor Jose Molina Orosa), and in the division of pediatric respiratory medicine of Hospital Universitario Donostia in the Basque Country, Spain.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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.         
Sponsors and Collaborators
Maria Pino-Yanes
University of La Laguna
Spanish Ministry of Science, Innovation, and Universities
Consorcio Centro de Investigación Biomédica en Red, M.P.
University Hospital of the Nuestra Señora de Candelaria
Hospital Universitario de Canarias
Hospital General de La Palma
Hospital Universitario Donostia
Hospital Doctor Jose Molina Orosa
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Pino-Yanes, University of La Laguna:
Genome-Wide Association Study
Microbiome, Human
Asthma
Epigenomics
Transcriptomics
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases