N/A
N=288
Non-Interventional Study to Describe the Clinical Management in Asthmatic Patients (NICMA)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT06811155 ↗Enrolled (actual)
288
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Clinical Management in Asthmatic Patients — 60; 64; 29; 41 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Universitario Virgen de la Victoria
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Management in Asthmatic Patients |
60; 64; 29; 41; 84; 40 | — |
| SECONDARY Sociodemographic and Clinical Characteristics |
185; 272; 3; 56; 269; 197 | — |
| SECONDARY Treatment Patterns. |
76; 14; 153; 25; 139; 6 | — |
| SECONDARY Level of Disease Control |
158; 130 | — |
| SECONDARY Use of Health Resources |
0.07; 0.13; 0.12; 0.13; 0.19; 0.12 | — |
| SECONDARY Number of Patients With SABA Discontinuation |
28 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient with written informed consent prior to participation.
- Patient female or male ≥ 18 years of age
- Patient with asthma diagnosis more than one year before the study inclusion
- Clinical data available at least 1 year before the study inclusion in the electronic medical records.
Exclusion Criteria
- Patient's participation in any clinical trial during the year prior to the index date for data collection.
Data sourced from ClinicalTrials.gov (NCT06811155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.