NCT06811155: (NICMA)

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

Completed Results posted Last updated 8 August 2025

What this trial tests

trial in Asthma in 288 participants. Completed in 30 September 2021.

Timeline

1 October 2020

Primary endpoint
30 August 2021

30 September 2021

Quick facts

Lead sponsor	Hospital Universitario Virgen de la Victoria
Status	Completed
Study type	OBSERVATIONAL
Enrollment	288
Start date	1 October 2020
Primary completion	30 August 2021
Estimated completion	30 September 2021
Sites	1 location across Spain

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Hospital Universitario Virgen de la Victoria

Who can join

18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Management in Asthmatic Patients Primary · Data collected for 6 months

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

Asthma diagnosis confirmed by spirometry and bronchodilator test

Group	Value	95% CI
Asthma Patients	60

Sensitization to allergen study in patients with history of suspected allergic asthma

Group	Value	95% CI
Asthma Patients	64

Smoker patients who were advised on the importance of stopping this habit

Group	Value	95% CI
Asthma Patients	29

Patients who were included in an educational plan

Group	Value	95% CI
Asthma Patients	41

Patient who were receiving inhaled glucocorticoids at inclusion date for persistent asthma treatment

Group	Value	95% CI
Asthma Patients	84

Patients who had an evaluation and documentation of exacerbations

Group	Value	95% CI
Asthma Patients	40

Sociodemographic and Clinical Characteristics Secondary · Data collected for 6 months

To describe the sociodemographic and clinical characteristics of the study population

Female gender

Group	Value	95% CI
Asthma Patients	185

White ethnicity

Group	Value	95% CI
Asthma Patients	272

Positive pregnancy status

Group	Value	95% CI
Asthma Patients	3

Chronic pulmonary disease comorbidity

Group	Value	95% CI
Asthma Patients	56

Patient's management in primary care

Group	Value	95% CI
Asthma Patients	269

Mild intermittent asthma severity degree according to GEMA guidelines

Group	Value	95% CI
Asthma Patients	197

Step 1 asthma therapeutic level according to GEMA stepwise therapy

Group	Value	95% CI
Asthma Patients	178

Treatment Patterns. Secondary · Data collected for 6 months

To describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment)

Short-acting β2 agonist (SABA)

Group	Value	95% CI
Asthma Patients	76

long-acting muscarinic antagonist (LAMA)

Group	Value	95% CI
Asthma Patients	14

Inhaled glucocorticoid (GCI)

Group	Value	95% CI
Asthma Patients	153

leukotriene receptor antagonist (LTRA)

Group	Value	95% CI
Asthma Patients	25

Long-acting β agonist (LABA) + Inhaled glucocorticoid (GCI)

Group	Value	95% CI
Asthma Patients	139

Biologic

Group	Value	95% CI
Asthma Patients	6

Inmunomodulator

Group	Value	95% CI
Asthma Patients	5

Oral corticosteroids (OCS)

Group	Value	95% CI
Asthma Patients	35

Level of Disease Control Secondary · Data collected for 6 months

To describe the disease control level in the study population

ACT score ≥20 (well-controlled asthma)

Group	Value	95% CI
Asthma Patients	158

ACT score <20 (uncontrolled asthma)

Group	Value	95% CI
Asthma Patients	130

Use of Health Resources Secondary · Data collected for 6 months

To describe the use of health resources (emergency visit, Primary care visits, specialist visits)

Mean number of emergencies visits due to asthma

Group	Value	95% CI
Asthma Patients	0.07	± 0.32

Mean number of unscheduled primary care visits due to asthma

Group	Value	95% CI
Asthma Patients	0.13	± 0.39

Mean number of scheduled primary care visits

Group	Value	95% CI
Asthma Patients	0.12	± 0.55

Mean number of unexpected primary care visits

Group	Value	95% CI
Asthma Patients	0.13	± 0.39

Mean number of allergology visits

Group	Value	95% CI
Asthma Patients	0.19	± 0.77

Mean number of pneumology visits

Group	Value	95% CI
Asthma Patients	0.12	± 0.42

Number of Patients With SABA Discontinuation Secondary · Data collected for 6 months

To describe the number of patients with SABA discontinuation

Group	Value	95% CI
Asthma Patients	28

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.