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NCT Number: NCT04442646

Role of "Asthma School" in Disease Management

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

•cognitive impairment

Treatment and study plan

multidisciplinary lessons

Behavioral

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

Primary outcomes

  1. number of exacerbations

    Time frame: 2 years

    number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

  2. ER accesses

    Time frame: 2 years

    ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

  3. number of asthma related hospitalizations

    Time frame: 2 years

    number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.

Secondary outcomes

  1. Asthma control test ACT (0-25)

    Time frame: 2 years

    evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).

  2. Asthma control questionnaire ACQ (0-6)

    Time frame: 2 years

    evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).

  3. St. George Respiratory questionnaire SGRQ (0-100)

    Time frame: 2 years

    assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).

  4. airways and systemic inflammation

    Time frame: 2 years

    differential 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

  5. respiratory function

    Time frame: 2 years

    Forced 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Visca, Prof.

CONTACT

[email protected]

0331829599

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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