Clinical trial NCT06811155: Non-Interventional Study to Describe the Clinical Management in Asthmatic Patients (NICMA)
Official title: Non-Interventional, Descriptive, Cross-sectional and Unicentric Study to Describe the Clinical Management in Asthmatic Patients Attended in the Influential Area of Hospital Universitario Virgen De La Victoria, Málaga
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
clinical management
exacerbations
Lead sponsor: Hospital Universitario Virgen de la Victoria
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2025-02-06
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patient with written informed consent prior to participation.
2. Patient female or male ≥ 18 years of age
3. Patient with asthma diagnosis more than one year before the study inclusion
4. Clinical data available at least 1 year before the study inclusion in the electronic medical records.

Exclusion Criteria:

1. Patient's participation in any clinical trial during the year prior to the index date for data collection.

Primary outcomes:
measure: Clinical management in asthmatic patients
timeFrame: 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 during the last 12 months.
Secondary outcomes:
measure: Describe the sociodemographic and clinical characteristics
timeFrame: To describe the sociodemographic and clinical characteristics of the study population during the last 12 months
measure: To describe the treatment patterns.
timeFrame: To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment) during the last 12 months
measure: Disease control
timeFrame: To describe the disease control level in the study population during the last 12 months
measure: Use of resources
timeFrame: To describe the use of resources (emergency visit, Primary care visits, specialist visits) during the last 12 months
measure: Potential impact on disease control level and use of resources.
timeFrame: To describe the number of patients with discontinuation of SABA within the last 12 months and the potential impact on disease control level and use of resources.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: HU Virgen de la Victoria
state: Malaga
Study officials:
References: