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

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: multidisciplinary lessons

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.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Visca, Prof.; Phone Number: 0331829599; Email: dina.visca@icsmaugeri.it

Study Locations

• Italy
  • Lombardy
    • Tradate, Lombardy, Italy, 21049
      • Recruiting
      • Istituti Clinici Maugeri Pneumologia
      • Contact: Dina Visca; Phone Number: +390331829409; Email: dina.visca@icsmaugeri.it
      • Sub-Investigator: Antonio Spanevello, MD
      • Contact: Francesca Cherubino; Phone Number: +390331829599; Email: francesca.cherubino@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

•cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASG= Asthma School Group, with educational intervention; experimental "asthma school" group (ASG) will attend control visits as Control Group every three months. In addiction, ASG will attend 3 further meetings consisting in multidisciplinary lessons (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	Behavioral: multidisciplinary 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
No Intervention: CG= Control Group, With no educational intervention; Control group will attend control visits every three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of exacerbations	number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.	2 years
ER accesses	ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.	2 years
number of asthma related hospitalizations	number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control test ACT (0-25)	evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).	2 years
Asthma control questionnaire ACQ (0-6)	evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).	2 years
St. George Respiratory questionnaire SGRQ (0-100)	assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).	2 years
airways and systemic inflammation	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	2 years
respiratory function	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).	2 years

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Investigators: Principal Investigator: Antonio Spanevello, Prof, ICS Maugeri

Publications and helpful links

General Publications

• Nair AS, DeMuth K, Chih-Wen Cheng, Wang MD. Asthma Academy: Developing educational technology to improve Asthma medication adherence and intervention efficiency. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:1364-1367. doi: 10.1109/EMBC.2017.8037086.
• Klijn SL, Hiligsmann M, Evers SMAA, Roman-Rodriguez M, van der Molen T, van Boven JFM. Effectiveness and success factors of educational inhaler technique interventions in asthma & COPD patients: a systematic review. NPJ Prim Care Respir Med. 2017 Apr 13;27(1):24. doi: 10.1038/s41533-017-0022-1.
• Muhlhauser I, Richter B, Kraut D, Weske G, Worth H, Berger M. Evaluation of a structured treatment and teaching programme on asthma. J Intern Med. 1991 Aug;230(2):157-64. doi: 10.1111/j.1365-2796.1991.tb00424.x.
• Ringsberg KC, Wiklund I, Wilhelmsen L. Education of adult patients at an "asthma school": effects on quality of life, knowledge and need for nursing. Eur Respir J. 1990 Jan;3(1):33-7.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 2278CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No