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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Asthma is a heterogenic chronic disease that affects more than 300 million people worldwide, which it's characterized by acute symptomatic episodes of varying severity, including intermittently inflammation and narrowing of the airways in the lungs.
The prevalence in Spain it is estimated to be around 5%, according to the European Community Respiratory Survey (ECRHS) and seems to be increased due to a higher rate of asthma diagnosis.
In this condition there's substantial proportion of patients with a poor disease control, which conducts to an important negative impact in their health-related quality of life (HRQoL) and the need to use health care resources.
During the past decades multiple clinical practice guidelines, such as the international Global Initiative for Asthma (GINA) and national guidelines as Guía Española para el Manejo del Asma (GEMA) have been launched with the aim of improving quality of care in patients with asthma and reduce the high public burden associated to this disease. However, several studies have concluded that high proportion of patients remain uncontrolled, being in Spain estimated around 50%, and there's direct evidence of poor adherence to the guideline's recommendations for asthma management.
This evidence raises the need to determine the assistance quality care in asthma population in the influential area of Hospital Universitario Virgen de la Victoria through the assistance quality care indicators established by GEMA guidelines. The aim of this study is to obtain clinical data that allow to assess assistance quality degree in order to find improvement opportunities to achieve a better control of asthmatic patients within this influential area.
A non-Interventional, descriptive, cross-sectional and unicentric study, has been designed and will be conducted in a Spanish hospital of Málaga. The design of the study imposes an only visit to be performed to obtain the patient's signed IC and after signing it (if patient agreed to participate in the study. Except for this study visit, the rest of study will be based on electronic medical chart review of approximately 300 asthma patients belonging the influential area of Hospital Universitario Virgen de la Victoria. This chart review will be performed by the site investigator or collaborators.
The data collection is stated in 6 months, and during this period the investigators will identify and randomly include the patients who meet selection criteria to avoid bias during patient's inclusion. The observational period will be conformed of 12 months, and the patient's data will be collected or documented in an electronic case report form (eCRF), which will automatically create or assign an identification numerical code to every patient the moment it's created in the electronic platform. This system guarantees the anonymization of each patient included in the study as no identifiable information won't be able to be captured.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Management in Asthmatic Patients | Describe the clinical management in asthmatic patients in the influential area of Hospital Universitario Virgen de la Victoria according to the assistance quality indicators established by GEMA guidelines | Data collected for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic and Clinical Characteristics | To describe the sociodemographic and clinical characteristics of the study population | Data collected for 6 months |
| Treatment Patterns. | To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient's participation in any clinical trial during the year prior to the index date for data collection.
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The study will be performed in Hospital Virgen de la Victoria, which it's the reference hospital that usually attends the asthma population of its influential area. Only patients that meet the eligibility criteria will be included in the study, and it is planned that a total estimation of 300 patients with asthma diagnose will be included in it. The whole patients will be recruited by the site investigator and collaborators, who will conduct the subject's medical chart review. Before the patient's study inclusion, the investigator team must have been obtained the signed informed consent of each patient recruited and according to ICH GCP and to local legal requirements.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HU Virgen de la Victoria | Málaga | Malaga | 29010 | Spain |
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A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Asthma Patients | A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients. Demographic and clinical characteristics of the participating patients are shown in
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| ID | Title | Description |
|---|---|---|
| BG000 | Asthma Patients | A total of 305 patients were screened for being included in the study. Of them, 17 patients did not meet all the eligibility criteria, with a final sample size of 288 patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Mean age at the time of the study visit (SD) (years) is 48.59 (14.91) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Management in Asthmatic Patients | Describe the clinical management in asthmatic patients in the influential area of Hospital Universitario Virgen de la Victoria according to the assistance quality indicators established by GEMA guidelines | The level of compliance was evaluated in the total study population (n=288) for row number 1, 4 and 6. For row number 2, we evaluated those patients included in the study with a history of allergic asthma (n=122). For row number 3, we evaluated the patients who were smokers at study entry (n=38). For row number 5, we evaluated patients with mild, moderate or severe persistent asthma (n=91). | Posted | Count of Participants | Participants | Data collected for 6 months |
|
Data collected for 6 months
no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Population | Population Description | 0 |
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The limitations of the study are linked to the retrospective design. The number of spirometry tests used to diagnose asthma may be underestimated. The spirometry tests used for diagnosis were not included in the database. In addition, other variables retrospectively collected from the medical charts may not be routinely recorded or inconsistently recorded by the clinicians (eg, inaccurate filling of the medical records).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| eva cabrera cesar | hospital universitario virgen de la victoria | 646905201 | evacabreracesar@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 1, 2019 | May 14, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Data collected for 6 months |
| Level of Disease Control | To describe the disease control level in the study population | Data collected for 6 months |
| Use of Health Resources | To describe the use of health resources (emergency visit, Primary care visits, specialist visits) | Data collected for 6 months |
| Number of Patients With SABA Discontinuation | To describe the number of patients with SABA discontinuation | Data collected for 6 months |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean age at the time of the study visit (SD) (years) 48.59 (14.91) | Mean | Standard Deviation | YEARS |
|
| Sex: Female, Male | Female gender, n (%) 185 (64.2%) | Count of Participants | Participants | No |
|
| Region of Enrollment | Adult patients diagnosed with asthma and followed-up in the influential area of Virgen de la Victoria University Hospital, referral hospital in Málaga (Spain) | Number | participants |
|
| Race (NIH/OMB) | We classify our population into: white, asian and latino or hispanic. | Count of Participants | Participants | No |
|
|
|
| Secondary | Sociodemographic and Clinical Characteristics | To describe the sociodemographic and clinical characteristics of the study population | We have only described the most prevalent demographic and clinical characteristic from the patients in the study. | Posted | Number | Participants | Data collected for 6 months |
|
|
|
| Secondary | Treatment Patterns. | To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment) | We have described the treatments patterns from all the patients in the study. | Posted | Number | Participants | Data collected for 6 months |
|
|
|
| Secondary | Level of Disease Control | To describe the disease control level in the study population | Posted | Count of Participants | Participants | Data collected for 6 months |
|
|
|
| Secondary | Use of Health Resources | To describe the use of health resources (emergency visit, Primary care visits, specialist visits) | Posted | Mean | Standard Deviation | Visits | Data collected for 6 months |
|
|
|
| Secondary | Number of Patients With SABA Discontinuation | To describe the number of patients with SABA discontinuation | Posted | Count of Participants | Participants | Data collected for 6 months |
|
|
|
| 288 |
| 0 |
| 288 |
| 0 |
| 288 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Positive pregnancy status |
|
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| Chronic pulmonary disease comorbidity |
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| Patient's management in primary care |
|
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| Mild intermittent asthma severity degree according to GEMA guidelines |
|
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| Step 1 asthma therapeutic level according to GEMA stepwise therapy |
|
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| Title | Measurements |
|---|---|
|
| leukotriene receptor antagonist (LTRA) |
|
| Long-acting β agonist (LABA) + Inhaled glucocorticoid (GCI) |
|
| Biologic |
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| Inmunomodulator |
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| Oral corticosteroids (OCS) |
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| Other |
|
| Measurements |
|---|
|
| Mean number of unexpected primary care visits |
|
| Mean number of allergology visits |
|
| Mean number of pneumology visits |
|