Chronic AsthmaMEGANCT06163807
Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
An observational study of Chronic Asthma, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 sites in Spain.
Trial summary
Primary objective To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment Secondary objective(s) To study biomarkers variation post-treatment in patients with and without Nasal Polyposis To demonstrate the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Asthma
- What is being tested?
- Antiasthmatic
- How many people
- 1,200 participants
- Where
- 8 sitesSpain
- Study dates
- 1 Feb 2025to 2 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with asthma (intermittent, mild, moderate or severe asthma according to the GINA classification), with or without nasal polyposis attended third-level hospitals of the Spanish National Health System.
Who may be able to join
- For the general asthma cohort (MEGA):
- Age from 18 to 80 y.o. with asthma with and without nasal polyposis based on GINA guidelines (compatible clinical symptoms+reversibility of at least 12% and 200 mL in FEV1 after the administration of 200-400 μg albuterol/salbutamol or positive methacholine test) of several severities attended at participant centres
- Already in follow-up in MEGA cohort
- To participate in the study
- Signed informed consent
- Inclusion criteria for asthma patients treated with biologics
Show all 11Show fewer
- Patients from 18 to 80 y.o. with uncontrolled asthma with and without nasal polyposis that fulfil criteria to be treated with biological drugs (Existing treatment with medium-to-high-dose ICS (≥ 250 μg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 μg/day of fluticasone propionate or equivalent) in combination with a second controller (e.g., LABA, LTRA) for at least 3 months+ airflow limitation- FEV1 <80%/FEV1/FVC <70+ACQ-5 score ≥ 1.5/ ACT < 19 at inclusion and/or have experience any of the following events on the last year: treatment with systemic steroids/ hospitalization or emergency medical care visit for worsening asthma.
- When planning dupilumab, mepolizumab, benralizumab or reslizumab, biomarker levels, and exacerbation in the previous year will be considered according to the Spanish Ministry of Health recommendations for reimbursement of any biological drug in severe asthma. In the case of Omalizumab allergic asthma and IgE > 75 and < 1500 UI
- Patients already in follow-up in the cohort of patients treated with biologics
- Willing to participate in the study
- Sign informed consent
Who cannot join
- Diagnosis of chronic obstructive pulmonary disease or other lung disease that may impair lung function
- Comorbid disease that might interfere with the evaluation, e.g. psychiatric disorders
- Patients participating in other clinical trials
- Patients without the capacity to understand the aim of the study
- Exclusion criteria for asthma patients treated with biologics
- Diagnosis of chronic obstructive pulmonary disease or other lung disease that may impair lung function
Show all 9Show fewer
- Comorbid disease that might interfere with the evaluation, e.g. psychiatric disorders
- Patients participating in other clinical trials
- Patients without the capacity to understand the aim of the study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Spain8 sites, 8 recruiting
- Recruiting
Hospital Del Ferrol
A Coruña, LA CORUÑA, 15405
MANUEL J RIAL, MD, PhD, 34 669174538, manuterial@gmail.com
- Recruiting
Hospital Universitario Germans Trias
Badalona, BARCELONA, 08916
CARLOS MARTINEZ-RIVERA, MD, PHD, 34934651200, carlosmartinezrivera.cmr@gmail.com
- Recruiting
Hospital Universitari Vall de Hebron
Barcelona, BARCELONA, 08035
XAVIER MUÑOZ, MD, PhD, 34934 893 000, xavier.munoz@vallhebron.cat
- Recruiting
Hospital Clinic
Barcelona, BARCELONA, 08036
EBYMAR ARISMENDI, MD, PhD, 3493 227 54 00, EARISMEN@clinic.cat
- Recruiting
Hospital Universitario Sant Pau
Barcelona, BARCELONA, 08041
LORENA SOTO, MD, PhD, 3493 556 57 75, LSoto@santpau.cat
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Santiago Quirce, MD, PhD, 34 659147570, squirce@gmail.com
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
JOSE MARIA OLAGUIBEL, MD, PhD, 34649063064, jm.olaguibel.rivera@navarra.es
- Recruiting
Hospital Universitario Santiago de Compostela
Santiago de Compostela, Acoruña, 15706
FRANCISCO JAVIER GONZALEZ-BARCALA, MD, PhD, +34607 819 141, fjgbarcala@gmail.com
About this study
Primary objective
- To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment
Secondary objective(s)
- To study biomarkers variation post-treatment in patients with and without Nasal Polyposis
- To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous
- To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).
Read the detailed description
Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up
- Correlation between non-invasive T2 markers (FeNO, blood eosinophils) versus inflammatory markers in sputum (eosinophils, periostin, NO, etc.)
- Cluster analysis in both cohorts.
- Analysis of some treatable traits on asthma control in MEGA cohort (BMI, anxiety and depression scale, exercise).
- To characterize exacerbations (numbers, ICU admissions, treatments compliance, etc).
- Analysis of compliance with asthma medications.
- Analysis of patients with phenotype T2-LOW in MEGA cohort.
- Analysis of patients with undetectable total IgE ( < 10 UI/L).
- Role of microRNA in diagnosis, follow-up and variations after treatments.
- Analysis of alarmins (TSLP, IL-33 e IL-25) and IL-6 in blood and sputum.
- To Immunophenotype eosinophils by single-cell analysis in blood and sputum at baseline and post-biological treatment.
- Conditions
- Chronic Asthma
- Being tested
- Antiasthmatic
- Keywords
- asthma, biologics, biomarkers, nasal polyposis, eosinophils
- Medical subject headings
- Asthma, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiasthmaticDrug
Also called biologics
real-life
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients with different severities | Asthma patients with different severities followed for 5 years. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques Receives: Drug: Antiasthmatic | |
| Severe asthma patients treated with biologics | In follow-up for 3 years and new patients. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques Receives: Drug: Antiasthmatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
biomarkers in blood (eosinophils, mRNA, periostine), exhaled nitric oxide (FeNO), sputum cell analysis and mRNA expression
Measured: at date of randomization and after one year of follow-up
Secondary outcomes (9)
Analysis of treatable traits on asthma control by ACT questionnaire
asthma control by Asthma Control Questionnaire (ACT)
Measured: at date of randomization and after one, two and three years of follow-up
To characterize asthma exacerbations.
number of exacerbations, type of exacerbation, ICU admissions, treatment compliance
Measured: at date of randomization and after one, two and three years of follow-up
Analysis of withdrawing asthma medications
percentage of anti-asthmatic medication withdrawn from the pharmacy in the electronic prescription with respect to that prescribed in your treatment
Measured: at date of randomization and after one, two and three years of follow-up
Analysis of patients with phenotype T2-LOW (IgE less than 75 kU/L, blood eosinophils less than 150 cells/μL, and FeNO less than 20 ppb)
number of exacerbations
Measured: at date of randomization and after one year of follow-up
Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)
Total IgE
Measured: at date of randomization and after one year of follow-up
Role of alarmins and IL-6 in the component of inflammation in asthma
measure of TSLP, IL-33 e IL-25 in blood and sputum
Measured: at date of randomization and after one year of follow-up
Role of microRNAs in asthma diagnosis and variations after different treatments
expression of mRNAs in blood and sputum
Measured: 1 year
Immunophenotype eosinophils
single-cell analysis of eosinophils in blood and sputum at baseline
Measured: 1 year
Stability of asthma phenotypes along the follow-up
% of eosinophils in sputum sample
Measured: at date of randomization and after one, two and three years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Feb 2025
- Primary completion2 Jun 2026 (estimated)
- Study completion2 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Joaquin Sastre, Study director, Fundacion Jimenez Diaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163807
- Sponsor's protocol ID
- SGZ-2022-13739
- Acronym
- MEGA
- Status last verified
- Apr 2025
- First submitted
- 2 Nov 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominguez-Ortega J, Luna-Porta JA, Olaguibel JM, Barranco P, Arismendi E, Barroso B, Betancor D, Bobolea I, Caballero ML, Cardaba B, Cruz MJ, Curto E, Gonzalez-Barcala FJ, Losantos-Garcia I, Martinez-Rivera C, Mendez-Brea P, Mullol J, Munoz X, Picado C, Plaza V, Del Pozo V, Rial MJ, Sastre J, Soto L, Valero A, Valverde-Monge M, Quirce S. Exacerbations Among Patients With Asthma Are Largely Dependent on the Presence of Multimorbidity. J Investig Allergol Clin Immunol. 2023 Jul 27;33(4):281-288. doi: 10.18176/jiaci.0816. Epub 2002 May 3.
PubMed 35503227Matabuena M, Salgado FJ, Nieto-Fontarigo JJ, Alvarez-Puebla MJ, Arismendi E, Barranco P, Bobolea I, Caballero ML, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Rodriguez-Garcia J, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Romero-Mesones C, Sastre B, Soto-Retes L, Valero A, Valverde-Monge M, Del Pozo V, Sastre J, Gonzalez-Barcala FJ. Identification of Asthma Phenotypes in the Spanish MEGA Cohort Study Using Cluster Analysis. Arch Bronconeumol. 2023 Apr;59(4):223-231. doi: 10.1016/j.arbres.2023.01.007. Epub 2023 Jan 18. English, Spanish.
PubMed 36732158Rodrigo-Munoz JM, Canas JA, Sastre B, Rego N, Greif G, Rial M, Minguez P, Mahillo-Fernandez I, Fernandez-Nieto M, Mora I, Barranco P, Quirce S, Sastre J, Del Pozo V. Asthma diagnosis using integrated analysis of eosinophil microRNAs. Allergy. 2019 Mar;74(3):507-517. doi: 10.1111/all.13570. Epub 2018 Oct 11.
PubMed 30040124Romero-Mesones C, Cruz MJ, Alobid I, Barroso B, Arismendi E, Barranco P, Betancor D, Bobolea I, Cardaba B, Curto E, Domenech G, Dominguez-Ortega J, Espejo D, Gonzalez-Barcala FJ, Luna-Porta JA, Martinez-Rivera C, Mendez-Brea P, Mullol J, Olaguibel JM, Picado C, Plaza V, Del Pozo V, Quirce S, Rial MJ, Rodrigo-Munoz JM, Sastre J, Serrano S, Soto-Retes L, Valero A, Valverde-Monge M, Munoz X. Disposition of Work-Related Asthma in a Spanish Asthma Cohort: Comparison of Asthma Severity Between Employed and Retired Workers. J Allergy Clin Immunol Pract. 2023 Nov;11(11):3407-3413.e1. doi: 10.1016/j.jaip.2023.06.040. Epub 2023 Jun 28.
PubMed 37391017Barroso B, Valverde-Monge M, Betancor D, Gomez-Lopez A, Villalobos-Vilda C, Gonzalez-Cano B, Sastre J. Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review. J Investig Allergol Clin Immunol. 2023 Dec 14;33(6):419-430. doi: 10.18176/jiaci.0939. Epub 2023 Sep 4.
PubMed 37669083Baos S, Calzada D, Cremades-Jimeno L, de Pedro M, Sastre J, Picado C, Quiralte J, Florido F, Lahoz C, Cardaba B. Discriminatory Molecular Biomarkers of Allergic and Nonallergic Asthma and Its Severity. Front Immunol. 2019 May 9;10:1051. doi: 10.3389/fimmu.2019.01051. eCollection 2019.
PubMed 31143187Baptista-Serna L, Rodrigo-Munoz JM, Minguez P, Valverde-Monge M, Arismendi E, Barranco P, Barroso B, Bobolea I, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Garcia-Latorre R, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Sastre B, Soto L, Valero A, Del Pozo V, Sastre J. Anxiety and body mass index affect asthma control: data from a prospective Spanish cohort. J Allergy Clin Immunol Pract. 2022 Mar;10(3):863-866.e1. doi: 10.1016/j.jaip.2021.10.013. Epub 2021 Oct 18. No abstract available.
PubMed 34673289Rial MJ, Alvarez-Puebla MJ, Arismendi E, Caballero ML, Canas JA, Cruz MJ, Gonzalez-Barcala FJ, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Romero-Mesones C, Salgado FJ, Sastre B, Soto-Retes L, Valero A, Valverde M, Sastre J, Pozo VD. Clinical and inflammatory characteristics of patients with asthma in the Spanish MEGA project cohort. Clin Transl Allergy. 2021 Mar;11(1):e12001. doi: 10.1002/clt2.12001.
PubMed 33900052Betancor D, Olaguibel JM, Rodrigo-Munoz JM, Arismendi E, Barranco P, Barroso B, Bobolea I, Cardaba B, Cruz MJ, Curto E, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Picado C, Plaza V, Quirce S, Rial MJ, Soto L, Valero A, Valverde-Monge M, Sastre J. How reliably can algorithms identify eosinophilic asthma phenotypes using non-invasive biomarkers? Clin Transl Allergy. 2022 Aug 20;12(8):e12182. doi: 10.1002/clt2.12182. eCollection 2022 Aug.
PubMed 36000018Rial MJ, Valverde M, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Munoz X, Olaguibel JM, Plaza V, Curto E, Quirce S, Barranco P, Dominguez-Ortega J, Mullol J, Picado C, Valero A, Bobolea I, Arismendi E, Ribo P, Sastre J. Clinical characteristics in 545 patients with severe asthma on biological treatment during the COVID-19 outbreak. J Allergy Clin Immunol Pract. 2021 Jan;9(1):487-489.e1. doi: 10.1016/j.jaip.2020.09.050. Epub 2020 Oct 9. No abstract available.
PubMed 33045398
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Spanish Prospective Asthma and Nasal Polyposis Registry
- ClinicalTrials.gov ID
- NCT06163807
- Acronym / sponsor ID
- MEGA / SGZ-2022-13739
- Conditions
- Chronic Asthma
- Keywords
- asthma, biologics, biomarkers, nasal polyposis, eosinophils
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 2 Jun 2026 (estimated)
- Study completion
- 2 Jun 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
Primary objective
- To study the stability of different phenotypes and endotypes of asthma at 3, 5, and 7 years of follow-up and - in MEGA COHORT and in patients on biologic treatment
Secondary objective(s)
- To study biomarkers variation post-treatment in patients with and without Nasal Polyposis
- To demonstrate the existence of different subtypes of eosinophils that may be phenotypically and functionally heterogeneous
- To increase the number of patients in the cohort on biologic treatment to reach at least 900 (400 over the current cohort).
Detailed description
Open-labeled National, Multicenter Non-interventional on the therapeutic strategy, Prospective (longitudinal) Disease registry, 3 years of follow-up
- Correlation between non-invasive T2 markers (FeNO, blood eosinophils) versus inflammatory markers in sputum (eosinophils, periostin, NO, etc.)
- Cluster analysis in both cohorts.
- Analysis of some treatable traits on asthma control in MEGA cohort (BMI, anxiety and depression scale, exercise).
- To characterize exacerbations (numbers, ICU admissions, treatments compliance, etc).
- Analysis of compliance with asthma medications.
- Analysis of patients with phenotype T2-LOW in MEGA cohort.
- Analysis of patients with undetectable total IgE ( < 10 UI/L).
- Role of microRNA in diagnosis, follow-up and variations after treatments.
- Analysis of alarmins (TSLP, IL-33 e IL-25) and IL-6 in blood and sputum.
- To Immunophenotype eosinophils by single-cell analysis in blood and sputum at baseline and post-biological treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma patients with different severities | – | Drug: AntiasthmaticAsthma patients with different severities followed for 5 years. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques |
| Severe asthma patients treated with biologics | – | Drug: AntiasthmaticIn follow-up for 3 years and new patients. Real-life, antiasthmatic drugs selected by investigators. Clinical, analytical, biomarkers, image techniques |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with asthma (intermittent, mild, moderate or severe asthma according to the GINA classification), with or without nasal polyposis attended third-level hospitals of the Spanish National Health System.
Key inclusion criteria (11 listed)
- Age from 18 to 80 y.o. with asthma with and without nasal polyposis based on GINA guidelines (compatible clinical symptoms+reversibility of at least 12% and 200 mL in FEV1 after the administration of 200-400 μg albuterol/salbutamol or positive methacholine test) of several severities attended at participant centres
- Already in follow-up in MEGA cohort
- To participate in the study
- Signed informed consent
- Inclusion criteria for asthma patients treated with biologics
Key exclusion criteria (9 listed)
- Exclusion criteria for asthma patients treated with biologics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiasthmaticAlso: biologicsreal-life | Drug | Asthma patients with different severities, Severe asthma patients treated with biologics |
Primary outcome
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum
Time frame: at date of randomization and after one year of follow-up
biomarkers in blood (eosinophils, mRNA, periostine), exhaled nitric oxide (FeNO), sputum cell analysis and mRNA expression
9 secondary outcomes
Analysis of treatable traits on asthma control by ACT questionnaire
Time frame: at date of randomization and after one, two and three years of follow-up
To characterize asthma exacerbations.
Time frame: at date of randomization and after one, two and three years of follow-up
Analysis of withdrawing asthma medications
Time frame: at date of randomization and after one, two and three years of follow-up
Analysis of patients with phenotype T2-LOW (IgE less than 75 kU/L, blood eosinophils less than 150 cells/μL, and FeNO less than 20 ppb)
Time frame: at date of randomization and after one year of follow-up
Analysis of clinical outcomes, pulmonary function tests, biomarkers patients with very low total IgE ( < 10 UI/L)
Time frame: at date of randomization and after one year of follow-up
Role of alarmins and IL-6 in the component of inflammation in asthma
Time frame: at date of randomization and after one year of follow-up
Role of microRNAs in asthma diagnosis and variations after different treatments
Time frame: 1 year
Immunophenotype eosinophils
Time frame: 1 year
Stability of asthma phenotypes along the follow-up
Time frame: at date of randomization and after one, two and three years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 35503227Dominguez-Ortega J, Luna-Porta JA, Olaguibel JM, Barranco P, Arismendi E, Barroso B, Betancor D, Bobolea I, Caballero ML, Cardaba B, Cruz MJ, Curto E, Gonzalez-Barcala FJ, Losantos-Garcia I, Martinez-Rivera C, Mendez-Brea P, Mullol J, Munoz X, Picado C, Plaza V, Del Pozo V, Rial MJ, Sastre J, Soto L, Valero A, Valverde-Monge M, Quirce S. Exacerbations Among Patients With Asthma Are Largely Dependent on the Presence of Multimorbidity. J Investig Allergol Clin Immunol. 2023 Jul 27;33(4):281-288. doi: 10.18176/jiaci.0816. Epub 2002 May 3.
- Results publication: PubMed 36732158Matabuena M, Salgado FJ, Nieto-Fontarigo JJ, Alvarez-Puebla MJ, Arismendi E, Barranco P, Bobolea I, Caballero ML, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Rodriguez-Garcia J, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Romero-Mesones C, Sastre B, Soto-Retes L, Valero A, Valverde-Monge M, Del Pozo V, Sastre J, Gonzalez-Barcala FJ. Identification of Asthma Phenotypes in the Spanish MEGA Cohort Study Using Cluster Analysis. Arch Bronconeumol. 2023 Apr;59(4):223-231. doi: 10.1016/j.arbres.2023.01.007. Epub 2023 Jan 18. English, Spanish.
- Results publication: PubMed 30040124Rodrigo-Munoz JM, Canas JA, Sastre B, Rego N, Greif G, Rial M, Minguez P, Mahillo-Fernandez I, Fernandez-Nieto M, Mora I, Barranco P, Quirce S, Sastre J, Del Pozo V. Asthma diagnosis using integrated analysis of eosinophil microRNAs. Allergy. 2019 Mar;74(3):507-517. doi: 10.1111/all.13570. Epub 2018 Oct 11.
- Results publication: PubMed 37391017Romero-Mesones C, Cruz MJ, Alobid I, Barroso B, Arismendi E, Barranco P, Betancor D, Bobolea I, Cardaba B, Curto E, Domenech G, Dominguez-Ortega J, Espejo D, Gonzalez-Barcala FJ, Luna-Porta JA, Martinez-Rivera C, Mendez-Brea P, Mullol J, Olaguibel JM, Picado C, Plaza V, Del Pozo V, Quirce S, Rial MJ, Rodrigo-Munoz JM, Sastre J, Serrano S, Soto-Retes L, Valero A, Valverde-Monge M, Munoz X. Disposition of Work-Related Asthma in a Spanish Asthma Cohort: Comparison of Asthma Severity Between Employed and Retired Workers. J Allergy Clin Immunol Pract. 2023 Nov;11(11):3407-3413.e1. doi: 10.1016/j.jaip.2023.06.040. Epub 2023 Jun 28.
- Results publication: PubMed 37669083Barroso B, Valverde-Monge M, Betancor D, Gomez-Lopez A, Villalobos-Vilda C, Gonzalez-Cano B, Sastre J. Improvement in Smell Using Monoclonal Antibodies Among Patients With Chronic Rhinosinusitis With Nasal Polyps: A Systematic Review. J Investig Allergol Clin Immunol. 2023 Dec 14;33(6):419-430. doi: 10.18176/jiaci.0939. Epub 2023 Sep 4.
- Results publication: PubMed 31143187Baos S, Calzada D, Cremades-Jimeno L, de Pedro M, Sastre J, Picado C, Quiralte J, Florido F, Lahoz C, Cardaba B. Discriminatory Molecular Biomarkers of Allergic and Nonallergic Asthma and Its Severity. Front Immunol. 2019 May 9;10:1051. doi: 10.3389/fimmu.2019.01051. eCollection 2019.
- Results publication: PubMed 34673289Baptista-Serna L, Rodrigo-Munoz JM, Minguez P, Valverde-Monge M, Arismendi E, Barranco P, Barroso B, Bobolea I, Canas JA, Cardaba B, Cruz MJ, Curto E, Dominguez-Ortega J, Garcia-Latorre R, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Rial MJ, Sastre B, Soto L, Valero A, Del Pozo V, Sastre J. Anxiety and body mass index affect asthma control: data from a prospective Spanish cohort. J Allergy Clin Immunol Pract. 2022 Mar;10(3):863-866.e1. doi: 10.1016/j.jaip.2021.10.013. Epub 2021 Oct 18. No abstract available.
- Results publication: PubMed 33900052Rial MJ, Alvarez-Puebla MJ, Arismendi E, Caballero ML, Canas JA, Cruz MJ, Gonzalez-Barcala FJ, Luna JA, Martinez-Rivera C, Mullol J, Munoz X, Olaguibel JM, Picado C, Plaza V, Quirce S, Romero-Mesones C, Salgado FJ, Sastre B, Soto-Retes L, Valero A, Valverde M, Sastre J, Pozo VD. Clinical and inflammatory characteristics of patients with asthma in the Spanish MEGA project cohort. Clin Transl Allergy. 2021 Mar;11(1):e12001. doi: 10.1002/clt2.12001.
- Results publication: PubMed 36000018Betancor D, Olaguibel JM, Rodrigo-Munoz JM, Arismendi E, Barranco P, Barroso B, Bobolea I, Cardaba B, Cruz MJ, Curto E, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Mullol J, Munoz X, Picado C, Plaza V, Quirce S, Rial MJ, Soto L, Valero A, Valverde-Monge M, Sastre J. How reliably can algorithms identify eosinophilic asthma phenotypes using non-invasive biomarkers? Clin Transl Allergy. 2022 Aug 20;12(8):e12182. doi: 10.1002/clt2.12182. eCollection 2022 Aug.
- Results publication: PubMed 33045398Rial MJ, Valverde M, Del Pozo V, Gonzalez-Barcala FJ, Martinez-Rivera C, Munoz X, Olaguibel JM, Plaza V, Curto E, Quirce S, Barranco P, Dominguez-Ortega J, Mullol J, Picado C, Valero A, Bobolea I, Arismendi E, Ribo P, Sastre J. Clinical characteristics in 545 patients with severe asthma on biological treatment during the COVID-19 outbreak. J Allergy Clin Immunol Pract. 2021 Jan;9(1):487-489.e1. doi: 10.1016/j.jaip.2020.09.050. Epub 2020 Oct 9. No abstract available.
- 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.
Joaquin Sastre study director
Fundacion Jimenez Diaz
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Asthma, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 8 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joaquin S Sastre (34609835363, jsastre@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between non-invasive T2 biomarkers versus biomarkers in sputum (time frame: at date of randomization and after one year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163807, which also lists 10 linked publications.
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 30 Mar 2026.