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AsthmaNCT03137043

Prevalence of Severe Asthma in Spanish Hospitals

An observational study of Asthma, run by GlaxoSmithKline at 33 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Questionnaire and Software of Big Data
How many people
356 participants
Where
33 sitesSpain
Study dates
22 Nov 2017to 2 Jun 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Spain33 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Cartagena (Murcia), 30202

  • GSK Investigational Site

    Elda (Alicante), 03600

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907

  • GSK Investigational Site

    La Laguna-Tenerife, 38320

  • GSK Investigational Site

    Laredo, Cantabria, 39770

  • GSK Investigational Site

    Lleida, 25198

  • GSK Investigational Site

    Loja/ Granada, 18300

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28031

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Majadahonda (Madrid), 28222

  • GSK Investigational Site

    Marbella, 29600

  • GSK Investigational Site

    Murcia (El Palmar), 30120

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Ponferrada (León), 24411

  • GSK Investigational Site

    Sagunto/Valencia, 46520

  • GSK Investigational Site

    Salamanca, 37007

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valdemoro/Madrid, 28340

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Valencia, 46026

  • GSK Investigational Site

    Xátiva-Valencia, 46800

  • GSK Investigational Site

    Zaragoza, 50009

  • GSK Investigational Site

    Zaragoza, 50015

Other trials in Spain

About this study

Official title: Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals

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).

Conditions
Asthma
Being tested
Questionnaire, Software of Big Data
Keywords
GINA guidelines, Prevalence, Mepolizumab, severe asthma, Spain
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    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.

  • Software of Big DataOther

    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.

Study groups in NCT03137043
Study groupRoleWhat they receive
Severe Asthmatic SubjectsSubjects 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.
Receives: Other: Questionnaire; Other: Software of Big Data
Non-Severe Asthmatic SubjectsSubjects with intermittent, persistent mild or moderate asthma.
Receives: Other: Questionnaire; Other: Software of Big Data

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To estimate the prevalence of severe asthmatic subjects at Spanish sites

    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.

    Measured: Up to 12 months

Secondary outcomes (13)

  1. Number of subjects with sociodemographic characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects

    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.

    Measured: Up to 12 months

  2. Number of subjects with clinical characteristics of severe asthmatic subjects compared to non-severe asthmatic subjects

    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.

    Measured: Up to 12 months

  3. To estimate the prevalence of different phenotypes in severe asthma

    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.

    Measured: Up to 12 months

  4. Number of subjects who comply with eligibility criteria to receive biological treatment for severe asthma

    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.

    Measured: Up to 12 months

  5. Number of subjects evolved with severe asthma and non-severe asthma at 6 and 12 months from baseline

    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.

    Measured: Up to 12 months

  6. Number of subjects evolved with severe asthma in comparison with non severe asthma at 6 and 12 months

    Subjects with severe and non severe asthma at 6 and 12 months will be compared.

    Measured: Up to 12 months

  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)

    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.

    Measured: Up to 12 months

  8. To assess the use of healthcare resources (direct and indirect) in subjects with severe asthma and non-severe asthma

    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.

    Measured: Up to 12 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

    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.

    Measured: Up to 12 months

  10. To establish the determinant factors clinicians use, to predict subjects evolution

    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.

    Measured: Up to 12 months

  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

    This will provide a descriptive comparison between the gold standard data and the software's prediction.

    Measured: Up to 12 months

  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

    This will provide a descriptive comparison between the clinician's prediction and the software's prediction.

    Measured: Up to 12 months

  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

    Gold standard data collected by monitoring will be compared against the real data.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2017
  2. Study start22 Nov 2017
  3. Primary completion2 Jun 2020
  4. Study completion2 Jun 2020

Resources

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
Prospective
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03137043
Sponsor's protocol ID
205807
Status last verified
Sep 2020
First submitted
27 Apr 2017
Last updated
21 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Almonacid Sanchez C, Melero Moreno C, Quirce Gancedo S, Sanchez-Herrero MG, Alvarez Gutierrez FJ, Banas Conejero D, Cardona V, Soriano JB. PAGE Study: Summary of a Study Protocol to Estimate the Prevalence of Severe Asthma in Spain Using Big Data Methods. J Investig Allergol Clin Immunol. 2021 Jul 26;31(4):308-315. doi: 10.18176/jiaci.0483. Epub 2020 Jan 23.

    PubMed 31983679

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by GlaxoSmithKline at 33 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 9 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To estimate the prevalence of severe asthmatic subjects at Spanish sites (time frame: Up to 12 months). 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 NCT03137043, which also lists 1 linked publication.

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 21 Sep 2020.

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