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Role of "Asthma School" in Disease Management

Role of "Asthma School" in Disease Management

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04442646
Enrollment
92
Registered
2020-06-22
Start date
2019-04-01
Completion date
2026-12-15
Last updated
2026-04-24

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

Conditions

Asthma

Brief summary

According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy.The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals

Detailed description

Asthma is a chronic inflammatory disease affecting 300 million people worldwide, especially children. In Italy, asthma affects 3 million patients and represents one of the main expenses of the Italian National Heath Care Service. According to the definition provided by the GINA guidelines, asthma is characterized by a variable and reversible limitation of expiratory airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow limitation can vary over time (1) depending on external agents, such as physical exercise, polluting agents, climate changes and viral infections. The therapy is mainly based on the use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (\ 10% of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if exposed to maximal doses of inhalation therapy. More than one third of severe asthma patients receive oral corticosteroids prescriptions, with the risk of severe and irreversible adverse events. Therapy adherence is generally poor when therapeutic regimes are prescribed for chronic diseases, including asthma (4). The behavioural sciences can potentially help to find the psychological factors behind scarce adherence and to develop strategies with the aim of improving the interactive processes between patients, medical doctors and health care professionals (4). Several studies have described intervention models focused on education of the patients to symptoms and exacerbations recognition, therapy management, reduction of the exposure to trigger agents and improvement of social and physical activities (5-6). The intervention is not able to make patients independent in disease managing, but can improve the cooperation in asthma management. Another important aspect in asthma management is the quality of the therapeutic intervention: the correct delivery of inhalation therapy is the key for the disease control (3). Specific educational intervention such as "asthma school" can improve symptoms control and reduce; however, up to day, a universal and standardized protocol is not available and further studies are needed.

Interventions

BEHAVIORALmultidisciplinary lessons

the multidisciplinary lessons will be conducted by study staff, formed by pneumologist, nurse, biologist and respiratory therapist once a week within 1 month after randomization. Study staff will deal with the following topics: asthma physiopathology, recognition of asthma symptoms and exacerbation, educational interventions on therapy and device, nutritional counselling if necessary. Patients will receive a paper diary for symptoms and an expiratory pick flow meter (PFM) to be done twice a day

Sponsors

Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Asthma diagnosis according to GINA / ATS guidelines. * Age ≥18 years

Exclusion criteria

•cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
number of exacerbations2 yearsnumber of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
ER accesses2 yearsER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
number of asthma related hospitalizations2 yearsnumber of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

Secondary

MeasureTime frameDescription
Asthma control test ACT (0-25)2 yearsevaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
Asthma control questionnaire ACQ (0-6)2 yearsevaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
St. George Respiratory questionnaire SGRQ (0-100)2 yearsassessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).
airways and systemic inflammation2 yearsdifferential cell count in sputum and blood in Asthma School Group (ASG) compared to Control Group (CG). Sputum inflammatio: number eosinophills \>3%, sistemic inflammation: eosiniphils cell count \>250 cell/ul
respiratory function2 yearsForced Expiratory Volume in 1 second (FEV1) l, %, Forced Volume Capacity (FVC) l,%, FEV1 / FVC% values in Asthma School Group (ASG) compared to Control Group (CG).

Countries

Italy

Contacts

CONTACTDina Visca, Prof.
dina.visca@icsmaugeri.it0331829599
PRINCIPAL_INVESTIGATORAntonio Spanevello, Prof

ICS Maugeri

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026