AsthmaGEMASNCT04501926
Genomics and Metagenomics of Asthma Severity
An observational study of Asthma and Asthma Attack, run by Maria Pino-Yanes at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 85 years
- Conditions the study is for
- Asthma, Asthma Attack
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Mar 2018to 31 Dec 2023
- 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 8 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 5 recruiting
- Recruiting
Hospital Doctor Jose Molina Orosa
Arrecife
Berta Roman-Bernal, MD
- Recruiting
Hospital General de La Palma
Breña Alta
Jose M Hernandez-Perez, MD, Ph.D.
- Active, not recruiting
University of La Laguna
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38200
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Ruperto Gonzalez-Perez, MD, Ph.D.
- Recruiting
Hospital Universitario Donostia
San Sebastián
Olaia Sardon, MD, Ph.D.
- Recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
Jose M Hernandez-Perez, MD, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Asthma, Asthma Attack
- Keywords
- Genome-Wide Association Study, Microbiome, Human, Asthma, Epigenomics, Transcriptomics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe asthma exacerbations
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
Measured: 1 year
Secondary outcomes (6)
Asthma control
Asthma control questionnaire (ACQ) score
Measured: 1 week
Asthma severity
Category of severity defined by treatment step according to GINA 2020 at recruitment
Measured: 1 year
Lung function measurement: forced expiratory volume in the first second (FEV1)
Baseline and post-bronchodilator measurements of the forced expiratory volume in the first second (FEV1) measured in liters
Measured: 3 months
Lung function measurement: forced vital capacity (FVC)
Baseline and post-bronchodilator measurements of the forced vital capacity (FVC) measured in liters
Measured: 3 months
Lung function measurement: FEV1/FVC ratio
The ratio of FEV1/FVC measurements
Measured: 3 months
Atopy testing
Atopy status evaluated by skin prick tests and/or specific immunoglobulin E (IgE) levels assessing the most common aeroallergens of each recruiting center
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Mar 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Pino-Yanes
- Sponsor type
- University, hospital or other
- Collaborators
- University of La Laguna, Ministry of Science and Innovation, Spain, Consorcio Centro de Investigación Biomédica en Red (CIBER), University Hospital of the Nuestra Señora de Candelaria, Hospital Universitario de Canarias, Hospital General de La Palma, Hospital Donostia, Hospital Universitario Doctor José Molina Orosa
- Responsible party
- Sponsor-investigator, Maria Pino-Yanes, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501926
- Sponsor's protocol ID
- PI-29/17
- Acronym
- GEMAS
- Status last verified
- May 2022
- First submitted
- 30 Jul 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics and Metagenomics of Asthma Severity
- ClinicalTrials.gov ID
- NCT04501926
- Acronym / sponsor ID
- GEMAS / PI-29/17
- Conditions
- Asthma, Asthma Attack
- Keywords
- Genome-Wide Association Study, Microbiome, Human, Asthma, Epigenomics, Transcriptomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maria Pino-YanesUniversity, hospital or other
- Collaborators
- University of La Laguna, Ministry of Science and Innovation, Spain, Consorcio Centro de Investigación Biomédica en Red (CIBER), University Hospital of the Nuestra Señora de Candelaria, Hospital Universitario de Canarias, Hospital General de La Palma, Hospital Donostia, Hospital Universitario Doctor José Molina Orosa
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Aug 2020 (actual)
- 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.
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 (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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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
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
6 secondary outcomes
Asthma control
Time frame: 1 week
Asthma severity
Time frame: 1 year
Lung function measurement: forced expiratory volume in the first second (FEV1)
Time frame: 3 months
Lung function measurement: forced vital capacity (FVC)
Time frame: 3 months
Lung function measurement: FEV1/FVC ratio
Time frame: 3 months
Atopy testing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Asthma Attack, run by Maria Pino-Yanes at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Pino-Yanes, Ph.D. (+34 922 316 502 ext. 6343, mdelpino@ull.edu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe asthma exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.