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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06811155
Acronym
(NICMA)
Enrollment
288
Registered
2025-02-06
Start date
2020-10-01
Completion date
2021-09-30
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, clinical management, exacerbations

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. 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.

Interventions

None listed

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Hospital Universitario Virgen de la Victoria
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Management in Asthmatic PatientsData collected for 6 monthsDescribe 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

Secondary

MeasureTime frameDescription
Sociodemographic and Clinical CharacteristicsData collected for 6 monthsTo describe the sociodemographic and clinical characteristics of the study population
Treatment Patterns.Data collected for 6 monthsTo describe the treatment patterns (maintenance treatment, reliever treatment, type of treatment)
Level of Disease ControlData collected for 6 monthsTo describe the disease control level in the study population
Use of Health ResourcesData collected for 6 monthsTo describe the use of health resources (emergency visit, Primary care visits, specialist visits)
Number of Patients With SABA DiscontinuationData collected for 6 monthsTo describe the number of patients with SABA discontinuation

Countries

Spain

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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
288
Total288

Baseline characteristics

CharacteristicAsthma Patients
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
52 Participants
Age, Categorical
Between 18 and 65 years
236 Participants
Age, Continuous48 YEARS
STANDARD_DEVIATION 14
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants
Race (NIH/OMB)
White
272 Participants
Region of Enrollment
Spain
288 participants
Sex: Female, Male
Female
185 Participants
Sex: Female, Male
Male
103 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 288
other
Total, other adverse events
0 / 288
serious
Total, serious adverse events
0 / 288

Outcome results

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

Time frame: Data collected for 6 months

Population: 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).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Asthma PatientsClinical Management in Asthmatic PatientsAsthma diagnosis confirmed by spirometry and bronchodilator test60 Participants
Asthma PatientsClinical Management in Asthmatic PatientsSensitization to allergen study in patients with history of suspected allergic asthma64 Participants
Asthma PatientsClinical Management in Asthmatic PatientsSmoker patients who were advised on the importance of stopping this habit29 Participants
Asthma PatientsClinical Management in Asthmatic PatientsPatients who were included in an educational plan41 Participants
Asthma PatientsClinical Management in Asthmatic PatientsPatient who were receiving inhaled glucocorticoids at inclusion date for persistent asthma treatment84 Participants
Asthma PatientsClinical Management in Asthmatic PatientsPatients who had an evaluation and documentation of exacerbations40 Participants
Secondary

Level of Disease Control

To describe the disease control level in the study population

Time frame: Data collected for 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Asthma PatientsLevel of Disease ControlACT score ≥20 (well-controlled asthma)158 Participants
Asthma PatientsLevel of Disease ControlACT score <20 (uncontrolled asthma)130 Participants
Secondary

Number of Patients With SABA Discontinuation

To describe the number of patients with SABA discontinuation

Time frame: Data collected for 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Asthma PatientsNumber of Patients With SABA Discontinuation28 Participants
Secondary

Sociodemographic and Clinical Characteristics

To describe the sociodemographic and clinical characteristics of the study population

Time frame: Data collected for 6 months

Population: We have only described the most prevalent demographic and clinical characteristic from the patients in the study.

ArmMeasureGroupValue (NUMBER)
Asthma PatientsSociodemographic and Clinical CharacteristicsWhite ethnicity272 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsPositive pregnancy status3 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsFemale gender185 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsChronic pulmonary disease comorbidity56 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsPatient's management in primary care269 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsMild intermittent asthma severity degree according to GEMA guidelines197 Participants
Asthma PatientsSociodemographic and Clinical CharacteristicsStep 1 asthma therapeutic level according to GEMA stepwise therapy178 Participants
Secondary

Treatment Patterns.

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

Time frame: Data collected for 6 months

Population: We have described the treatments patterns from all the patients in the study.

ArmMeasureGroupValue (NUMBER)
Asthma PatientsTreatment Patterns.Short-acting β2 agonist (SABA)76 Participants
Asthma PatientsTreatment Patterns.long-acting muscarinic antagonist (LAMA)14 Participants
Asthma PatientsTreatment Patterns.Inhaled glucocorticoid (GCI)153 Participants
Asthma PatientsTreatment Patterns.leukotriene receptor antagonist (LTRA)25 Participants
Asthma PatientsTreatment Patterns.Long-acting β agonist (LABA) + Inhaled glucocorticoid (GCI)139 Participants
Asthma PatientsTreatment Patterns.Biologic6 Participants
Asthma PatientsTreatment Patterns.Inmunomodulator5 Participants
Asthma PatientsTreatment Patterns.Oral corticosteroids (OCS)35 Participants
Asthma PatientsTreatment Patterns.Other12 Participants
Secondary

Use of Health Resources

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

Time frame: Data collected for 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Asthma PatientsUse of Health ResourcesMean number of emergencies visits due to asthma0.07 VisitsStandard Deviation 0.32
Asthma PatientsUse of Health ResourcesMean number of unscheduled primary care visits due to asthma0.13 VisitsStandard Deviation 0.39
Asthma PatientsUse of Health ResourcesMean number of scheduled primary care visits0.12 VisitsStandard Deviation 0.55
Asthma PatientsUse of Health ResourcesMean number of unexpected primary care visits0.13 VisitsStandard Deviation 0.39
Asthma PatientsUse of Health ResourcesMean number of allergology visits0.19 VisitsStandard Deviation 0.77
Asthma PatientsUse of Health ResourcesMean number of pneumology visits0.12 VisitsStandard Deviation 0.42

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026