Non-Interventional Study to Describe the Clinical Management in Asthmatic Patients (NICMA)

NCT06811155 | Completed Results DMC

• 1 other identifier: FIS-ASP-2020-01
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; clinical management; exacerbations

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Sociodemographic and Clinical Characteristics

  Data collected for 6 months

• Treatment Patterns.

  Data collected for 6 months

• Level of Disease Control

  Data collected for 6 months

• Use of Health Resources

  Data collected for 6 months

• Number of Patients With SABA Discontinuation

  Data collected for 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient with written informed consent prior to participation.
• Patient female or male ≥ 18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Virgen de la Victoria: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

HU Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

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).

Results Point of Contact

• Title: eva cabrera cesar
• Organization: hospital universitario virgen de la victoria

evacabreracesar@gmail.com

646905201

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: February 6, 2025
• Study Start: October 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)