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Prevalence of Severe Asthma in Spanish Hospitals

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ClinicalTrials.gov Identifier: NCT03137043
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Quintiles IMS
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1 in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence of non-controlled severe asthma.

This prospective, non-interventional, observational, multicenter and case-control study aims to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to receive biological treatments approved for this disease, resource consumption and evaluate the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided into two cohorts, based on asthma severity according to the Global Initiative for Asthma (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic subjects will be enrolled in the study. A software of big data will be used to do a sub study for comparing the results obtained through this software tool against results obtained through Gold standard classical methods used in this prospective observational study (the descriptive assessment of severe asthma prevalence and the prospective evolution of subjects).


Condition or disease Intervention/treatment
Asthma Other: Questionnaire Other: Software of Big Data

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Severe Asthmatic Subjects
Subjects requiring high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic glucocorticosteroids) to prevent it from becoming 'uncontrolled' or which remains 'uncontrolled' despite the therapy.
Other: Questionnaire
Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.

Other: Software of Big Data
Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.

Non-Severe Asthmatic Subjects
Subjects with intermittent, persistent mild or moderate asthma.
Other: Questionnaire
Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.

Other: Software of Big Data
Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.




Primary Outcome Measures :
  1. To estimate the prevalence of severe asthmatic subjects at Spanish sites [ Time Frame: Up to 12 months ]
    Assessment will be done based on the type of hospital, department type of hospital or clinic, sources of the service and number of asthmatic subjects diagnosed according to GEMA guidelines.


Secondary Outcome Measures :
  1. Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects [ Time Frame: Up to 12 months ]
    Subjects with different age, gender, ethnicity, education, occupational status, marital status, physical examination, smoking status, family history, co-morbidities and allergies will be compared for descriptive analysis of sociodemographic characteristics of subjects with severe asthma and non-severe asthma participating in this study.

  2. Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects [ Time Frame: Up to 12 months ]
    Subjects with asthma severity, age of asthma onset, laboratory tests, biomarkers, skin prick test, airflow tests, asthma symptoms and exacerbations will be compared for clinical characteristics analysis of subjects with severe asthma and non-severe asthma participating in this study.

  3. To estimate the prevalence of different phenotypes in severe asthma [ Time Frame: Up to 12 months ]
    Prevalence of different severe asthma phenotypes (allergic, base on prick test, Immunoglobulin E (IgE), eosinophilic, based on eosinophils counts >= 300 cells/millimeter cubed in blood samples in the previous year, obesity, based on the absence of positive prick test, IgE or high eosinophils counts in blood sample; neutrophilic, just in case eosinophils in sputum are available.

  4. Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma [ Time Frame: Up to 12 months ]
    Number of exacerbations; Oral Corticosteroid (OCS) treatment; Number of visits to emergency room (ER) and/or hospitalization within the last 12 months, sputum eosinophils (if done), eosinophils in blood, IgE (specific and total), forced expiratory volume-one second (FEV1), Asthma Control Test (ACT), percentage of reversibility will be assessed.

  5. Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline [ Time Frame: Up to 12 months ]
    Exacerbations; visits to emergency room; changes in treatment or dose increase, add-on therapy addition, Disease control (3-score change in ACT), Disease control state (uncontrolled, partially controlled, well controlled) according to guidelines, Quality of life (4-score change in SGRQ), mortality will be assessed.

  6. Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months [ Time Frame: Up to 12 months ]
    Subjects with severe and non severe asthma at 6 and 12 months will be compared.

  7. To assess the social impact of subjects with severe asthma in comparison with non-severe asthmatic subjects in terms of Health Related Quality of Life (HRQoL) [ Time Frame: Up to 12 months ]
    Health Related Quality of Life (HRQoL) will be analyzed from the SGRQ Questionnaire scores. Scores will be expressed as percentage of overall impairment, where 100 represents worst possible health and 0 indicates best possible health status.

  8. To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma [ Time Frame: Up to 12 months ]
    Direct resources will include number of inpatient admissions, emergency and hospitalized visits, tests to be conducted, etc. on patients with severe asthma. The medical resources used (tests, admissions, etc.) will be analyzed descriptively during the observation period. The direct cost will be calculated by taking into account the resources used and unit costs at a local level. Indirect resources will include reduced productivity of patients with severe asthma through an ad-hoc questions like total number of work days lost due to asthma in the last 6 months.

  9. To predict evolution of subjects with severe and non-severe asthma at month 6 and month 12, based on the physician's experience and knowledge, compared to results obtained through monitoring [ Time Frame: Up to 12 months ]
    The variables to be predicted will be exacerbations; visits to ER; changes in treatment or dose increase; add-on therapy addition; disease control (3-score change in ACT); disease control state (uncontrolled, partially controlled, well controlled) according to guidelines, Quality of life (4-score change in SGRQ) and mortality will be assessed.

  10. To establish the determinant factors clinicians use, to predict subjects evolution [ Time Frame: Up to 12 months ]
    FEV1 (pre & post), percentage reversibility FEV1, number of exacerbations, use of rescue medication, changes to the treatment required, need for adding a biological treatment, concomitant diseases or comorbidities, asthma symptoms; tobacco, eosinophils in blood or sputum, Asthma Control measured by ACT, number or hospitalizations; number of emergency department visits; dose of inhaled glucocorticosteroids, need and dose of oral glucocortocosteroids, mortality, adherence to medication, inhaler technique, fractionated exhaled nitric oxide level (FeNO), Body Mass Index (BMI), GINA treatment Step, living in a rural environment, chronic obstructive pulmonary disease (COPD), male sex, black race, lower educational level will be the determining factor for clinicians.

  11. To test if the calculated prevalence using a specific software is similar to the prevalence of severe asthma obtained through monitoring using gold standard [ Time Frame: Up to 12 months ]
    This will provide a descriptive comparison between the gold standard data and the software's prediction.

  12. To compare the prediction in the evolution of subjects with severe asthma at 6 and 12 months, based on the aggregated information collected in the last 5 years previous to the start of the observational study with the prediction done by the physician [ Time Frame: Up to 12 months ]
    This will provide a descriptive comparison between the clinician's prediction and the software's prediction.

  13. To compare the software's prediction in the evolution of subjects with severe asthma at 6 and 12 months with the results obtained by monitoring in the observational study [ Time Frame: Up to 12 months ]
    Gold standard data collected by monitoring will be compared against the real data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The severe asthmatic subjects according to the ATS/ERS Guidelines will enter into the prospective phase of the study. Non-severe asthmatic subjects will be also enrolled as a control group.
Criteria

Inclusion Criteria

  • Group A: Subjects with Severe asthma can be enrolled, when they fulfill the following criteria:
  • Subjects >= 18 years
  • Subjects diagnosed with "severe asthma" defined as asthma that requires high-dose inhaled corticosteroids (ICS) plus Long-Acting Beta2-Agonist (LABA), leukotriene modifier/ theophylline in the last 12 months or continuous/almost continuous treatment with systemic glucocorticosteroids (CS) for >= 50% of the previous year to maintain control of asthma
  • Subjects treated with ICS/LABA, with the maximum dose recommended by Specific Product Characteristics (SPC).
  • Subjects who give voluntary written informed consent after explanation of study´s procedures.
  • Group B: Subjects with Non-Severe asthma can be enrolled, when they fulfill the following criteria:
  • Subjects >= 18 years
  • Subjects diagnosed with non-severe asthma per GINA Guidelines Classification
  • Subjects who give voluntary written informed consent after explanation of study´s procedures

Exclusion Criteria

  • Subjects who are not able to complete all the follow-ups of the study with all the study procedures

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): NCT03137043


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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Spain
GSK Investigational Site Recruiting
Badalona, Spain, 08916
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carlos Martínez Rivera         
GSK Investigational Site Recruiting
Barcelona, Spain, 08035
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Olga Luengo Sánchez         
GSK Investigational Site Recruiting
Cáceres, Spain, 10003
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Agustín Sojo González         
GSK Investigational Site Recruiting
Elda (Alicante), Spain, 03600
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ana Isabel Gutiérrez Rubio         
GSK Investigational Site Recruiting
L'Hospitalet de Llobregat, Spain, 08907
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ramón Lleonart Bellfill         
GSK Investigational Site Recruiting
La Coruña, Spain, 15006
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marina Blanco Aparicio         
GSK Investigational Site Recruiting
La Laguna-Tenerife, Spain, 38320
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Paloma Poza Guedes         
GSK Investigational Site Recruiting
Loja/ Granada, Spain, 18300
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Bernardino Alcázar Navarrete         
GSK Investigational Site Recruiting
Lérida, Spain, 25198
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: LLuís Marqués Amat         
GSK Investigational Site Recruiting
Madrid, Spain, 28006
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carolina Cisneros Serrano         
GSK Investigational Site Recruiting
Madrid, Spain, 28007
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Luis Puente Maestu         
GSK Investigational Site Recruiting
Madrid, Spain, 28034
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carlos Almonacid Sánchez         
GSK Investigational Site Recruiting
Madrid, Spain, 28040
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: María del Mar Fernández Nieto         
GSK Investigational Site Recruiting
Madrid, Spain, 28041
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rocío Díaz Campos         
GSK Investigational Site Recruiting
Majadahonda (Madrid), Spain, 28222
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Antolín López Vina         
GSK Investigational Site Recruiting
Manresa (Barcelona), Spain, 08243
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: María Peña Peloche         
GSK Investigational Site Recruiting
Marbella, Spain, 29600
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alicia Padilla Galo         
GSK Investigational Site Recruiting
Pamplona, Spain, 31008
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pilar Cebollero Rivas         
GSK Investigational Site Recruiting
Ponferrada (León), Spain, 24411
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Juan Ortiz de Saracho         
GSK Investigational Site Recruiting
Sagunto/Valencia, Spain, 46520
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marta Palop Cervera         
GSK Investigational Site Recruiting
Salamanca, Spain, 37007
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ignacio Dávila González         
GSK Investigational Site Recruiting
Santander, Spain, 39008
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Fernando Rodríguez Fernández         
GSK Investigational Site Recruiting
Santiago de Compostela, Spain, 15706
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Francisco Javier González Barcala         
GSK Investigational Site Recruiting
Sevilla, Spain, 41013
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Francisco Javier Álvarez Gutiérrez         
GSK Investigational Site Recruiting
Valdemoro/Madrid, Spain, 28340
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Aythamy Henríquez Santana         
GSK Investigational Site Recruiting
Valencia, Spain, 46017
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eva María Martínez Moragón         
GSK Investigational Site Recruiting
Valencia, Spain, 46026
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Miguel Ángel Díaz Palacios         
GSK Investigational Site Recruiting
Xátiva-Valencia, Spain, 46800
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Luis Ángel Navarro Seisdedos         
GSK Investigational Site Recruiting
Zaragoza, Spain, 50009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carlos Colás Sanz         
GSK Investigational Site Recruiting
Zaragoza, Spain, 50015
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +440208-990-4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: José Ángel Carretero García         
Sponsors and Collaborators
GlaxoSmithKline
Quintiles IMS
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03137043     History of Changes
Other Study ID Numbers: 205807
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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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 GlaxoSmithKline:
GINA guidelines
Prevalence
Mepolizumab
severe asthma
Spain

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