NCT04501926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

5.8 years

First QC Date

July 30, 2020

Last Update Submit

May 16, 2022

Conditions

AsthmaAsthma Attack

Keywords

Genome-Wide Association StudyMicrobiome, HumanAsthmaEpigenomicsTranscriptomics

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (6)

  • Asthma control

    1 week

  • Asthma severity

    1 year

  • Lung function measurement: forced expiratory volume in the first second (FEV1)

    3 months

  • Lung function measurement: forced vital capacity (FVC)

    3 months

  • Lung function measurement: FEV1/FVC ratio

    3 months

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age8 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of La Laguna

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38200, Spain

ACTIVE NOT RECRUITING

Hospital Doctor Jose Molina Orosa

Arrecife, Spain

RECRUITING

Hospital General de La Palma

Breña Alta, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Maria Pino-Yanes, Ph.D.

CONTACT

+34 922 316 502mdelpino@ull.edu.es

Fabian Lorenzo-Diaz, Ph.D.

CONTACT

+34 922 316 502florenzo@ull.edu.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ramon y Cajal Fellow and Lecturer

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 6, 2020

Study Start

March 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(6)