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Prevalence of Severe Asthma in Spanish Hospitals

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ClinicalTrials.gov Identifier: NCT03137043
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Quintiles IMS
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date April 27, 2017
First Posted Date May 2, 2017
Last Update Posted Date September 21, 2020
Actual Study Start Date November 22, 2017
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 27, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Severe Asthma in Spanish Hospitals
Official Title Observational Study to Describe the Prevalence of Severe Asthma in Spanish Hospitals
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Asthma
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Other: Questionnaire
    • Other: Software of Big Data
  • Non-Severe Asthmatic Subjects
    Subjects with intermittent, persistent mild or moderate asthma.
    Interventions:
    • Other: Questionnaire
    • Other: Software of Big Data
Publications * Almonacid Sánchez C, Melero Moreno C, Quirce Gancedo S, Sánchez-Herrero MG, Álvarez Gutiérrez FJ, Bañas 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. 2020 Jan 23:0. doi: 10.18176/jiaci.0483. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2020)
356
Original Estimated Enrollment
 (submitted: April 27, 2017)
1600
Actual Study Completion Date June 2, 2020
Actual Primary Completion Date June 2, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03137043
Other Study ID Numbers 205807
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Quintiles IMS
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2020