Trial Outcomes & Findings for Non-Interventional Study to Describe the Clinical Management in Asthmatic Patients (NICMA) (NCT NCT06811155)

NCT ID: NCT06811155

Last Updated: 2025-08-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 288 participants
• Primary outcome timeframe: Data collected for 6 months
• Results posted on: 2025-08-08

Participant Flow

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

Participant milestones

Measure	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
Overall Study STARTED	288
Overall Study COMPLETED	288
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Asthma Patients n=288 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	236 Participants n=5 Participants
Age, Categorical >=65 years	52 Participants n=5 Participants
Age, Continuous	48 YEARS STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	185 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants
Region of Enrollment Spain	288 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	272 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Clinical Management in Asthmatic Patients Asthma diagnosis confirmed by spirometry and bronchodilator test	60 Participants
Clinical Management in Asthmatic Patients Sensitization to allergen study in patients with history of suspected allergic asthma	64 Participants
Clinical Management in Asthmatic Patients Smoker patients who were advised on the importance of stopping this habit	29 Participants
Clinical Management in Asthmatic Patients Patients who were included in an educational plan	41 Participants
Clinical Management in Asthmatic Patients Patient who were receiving inhaled glucocorticoids at inclusion date for persistent asthma treatment	84 Participants
Clinical Management in Asthmatic Patients Patients who had an evaluation and documentation of exacerbations	40 Participants

SECONDARY outcome

Timeframe: Data collected for 6 months

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

To describe the sociodemographic and clinical characteristics of the study population

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Sociodemographic and Clinical Characteristics Female gender	185 Participants
Sociodemographic and Clinical Characteristics White ethnicity	272 Participants
Sociodemographic and Clinical Characteristics Positive pregnancy status	3 Participants
Sociodemographic and Clinical Characteristics Chronic pulmonary disease comorbidity	56 Participants
Sociodemographic and Clinical Characteristics Patient's management in primary care	269 Participants
Sociodemographic and Clinical Characteristics Mild intermittent asthma severity degree according to GEMA guidelines	197 Participants
Sociodemographic and Clinical Characteristics Step 1 asthma therapeutic level according to GEMA stepwise therapy	178 Participants

SECONDARY outcome

Timeframe: Data collected for 6 months

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

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

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Treatment Patterns. Biologic	6 Participants
Treatment Patterns. Short-acting β2 agonist (SABA)	76 Participants
Treatment Patterns. long-acting muscarinic antagonist (LAMA)	14 Participants
Treatment Patterns. Inhaled glucocorticoid (GCI)	153 Participants
Treatment Patterns. leukotriene receptor antagonist (LTRA)	25 Participants
Treatment Patterns. Long-acting β agonist (LABA) + Inhaled glucocorticoid (GCI)	139 Participants
Treatment Patterns. Inmunomodulator	5 Participants
Treatment Patterns. Oral corticosteroids (OCS)	35 Participants
Treatment Patterns. Other	12 Participants

SECONDARY outcome

Timeframe: Data collected for 6 months

To describe the disease control level in the study population

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Level of Disease Control ACT score ≥20 (well-controlled asthma)	158 Participants
Level of Disease Control ACT score <20 (uncontrolled asthma)	130 Participants

SECONDARY outcome

Timeframe: Data collected for 6 months

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

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Use of Health Resources Mean number of unexpected primary care visits	0.13 Visits Standard Deviation 0.39
Use of Health Resources Mean number of allergology visits	0.19 Visits Standard Deviation 0.77
Use of Health Resources Mean number of emergencies visits due to asthma	0.07 Visits Standard Deviation 0.32
Use of Health Resources Mean number of unscheduled primary care visits due to asthma	0.13 Visits Standard Deviation 0.39
Use of Health Resources Mean number of scheduled primary care visits	0.12 Visits Standard Deviation 0.55
Use of Health Resources Mean number of pneumology visits	0.12 Visits Standard Deviation 0.42

SECONDARY outcome

Timeframe: Data collected for 6 months

To describe the number of patients with SABA discontinuation

Outcome measures

Measure	Asthma Patients n=288 Participants 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
Number of Patients With SABA Discontinuation	28 Participants

Adverse Events

Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

eva cabrera cesar

hospital universitario virgen de la victoria

Phone: 646905201

Email: evacabreracesar@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place