<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04442646</url>
  </required_header>
  <id_info>
    <org_study_id>2278CE</org_study_id>
    <nct_id>NCT04442646</nct_id>
  </id_info>
  <brief_title>Role of &quot;Asthma School&quot; in Disease Management</brief_title>
  <official_title>Role of &quot;Asthma School&quot; in Disease Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      . According to the definition provided by the GINA guidelines, asthma is characterized by a&#xD;
      variable and reversible limitation of expiratory airflow and by the following symptoms:&#xD;
      wheezing, dyspnoea, thoracic constriction and/or cough. The type and the severity of airflow&#xD;
      limitation can vary over time (1) depending on external agents, such as physical exercise,&#xD;
      polluting agents, climate changes and viral infections. The therapy is mainly based on the&#xD;
      use of inhaled corticosteroids and bronchodilators. Patients affected by severe asthma (~ 10%&#xD;
      of total prevalence of asthma and at high risk of exacerbations and/or hospitalization) may&#xD;
      not control their symptoms, even if exposed to maximal doses of inhalation therapy.The&#xD;
      behavioural sciences can potentially help to find the psychological factors behind scarce&#xD;
      adherence and to develop strategies with the aim of improving the interactive processes&#xD;
      between patients, medical doctors and health care professionals&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a chronic inflammatory disease affecting 300 million people worldwide, especially&#xD;
      children. In Italy, asthma affects 3 million patients and represents one of the main expenses&#xD;
      of the Italian National Heath Care Service. According to the definition provided by the GINA&#xD;
      guidelines, asthma is characterized by a variable and reversible limitation of expiratory&#xD;
      airflow and by the following symptoms: wheezing, dyspnoea, thoracic constriction and/or&#xD;
      cough. The type and the severity of airflow limitation can vary over time (1) depending on&#xD;
      external agents, such as physical exercise, polluting agents, climate changes and viral&#xD;
      infections. The therapy is mainly based on the use of inhaled corticosteroids and&#xD;
      bronchodilators. Patients affected by severe asthma (~ 10% of total prevalence of asthma and&#xD;
      at high risk of exacerbations and/or hospitalization) may not control their symptoms, even if&#xD;
      exposed to maximal doses of inhalation therapy. More than one third of severe asthma patients&#xD;
      receive oral corticosteroids prescriptions, with the risk of severe and irreversible adverse&#xD;
      events. Therapy adherence is generally poor when therapeutic regimes are prescribed for&#xD;
      chronic diseases, including asthma (4). The behavioural sciences can potentially help to find&#xD;
      the psychological factors behind scarce adherence and to develop strategies with the aim of&#xD;
      improving the interactive processes between patients, medical doctors and health care&#xD;
      professionals (4). Several studies have described intervention models focused on education of&#xD;
      the patients to symptoms and exacerbations recognition, therapy management, reduction of the&#xD;
      exposure to trigger agents and improvement of social and physical activities (5-6). The&#xD;
      intervention is not able to make patients independent in disease managing, but can improve&#xD;
      the cooperation in asthma management. Another important aspect in asthma management is the&#xD;
      quality of the therapeutic intervention: the correct delivery of inhalation therapy is the&#xD;
      key for the disease control (3). Specific educational intervention such as &quot;asthma school&quot;&#xD;
      can improve symptoms control and reduce; however, up to day, a universal and standardized&#xD;
      protocol is not available and further studies are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of exacerbations</measure>
    <time_frame>2 years</time_frame>
    <description>number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ER accesses</measure>
    <time_frame>2 years</time_frame>
    <description>ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of asthma related hospitalizations</measure>
    <time_frame>2 years</time_frame>
    <description>number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asthma control test ACT (0-25)</measure>
    <time_frame>2 years</time_frame>
    <description>evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma control questionnaire ACQ (0-6)</measure>
    <time_frame>2 years</time_frame>
    <description>evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. George Respiratory questionnaire SGRQ (0-100)</measure>
    <time_frame>2 years</time_frame>
    <description>assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>airways and systemic inflammation</measure>
    <time_frame>2 years</time_frame>
    <description>differential cell count in sputum and blood in Asthma School Group (ASG) compared to Control Group (CG). Sputum inflammatio: number eosinophills &gt;3%, sistemic inflammation: eosiniphils cell count &gt;250 cell/ul</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory function</measure>
    <time_frame>2 years</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>ASG= Asthma School Group, with educational intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>experimental &quot;asthma school&quot; 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CG= Control Group, With no educational intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will attend control visits every three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>multidisciplinary lessons</intervention_name>
    <description>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</description>
    <arm_group_label>ASG= Asthma School Group, with educational intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asthma diagnosis according to GINA / ATS guidelines.&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Spanevello, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICS Maugeri</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dina Visca, Prof.</last_name>
    <phone>0331829599</phone>
    <email>dina.visca@icsmaugeri.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Istituti Clinici Maugeri Pneumologia</name>
      <address>
        <city>Tradate</city>
        <state>Lombardia</state>
        <zip>21049</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dina Visca</last_name>
      <phone>+390331829409</phone>
      <email>dina.visca@icsmaugeri.it</email>
    </contact>
    <contact_backup>
      <last_name>Francesca Cherubino</last_name>
      <phone>+390331829599</phone>
      <email>francesca.cherubino@icsmaugeri.it</email>
    </contact_backup>
    <investigator>
      <last_name>Antonio Spanevello, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>29060130</PMID>
  </reference>
  <reference>
    <citation>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 &amp; COPD patients: a systematic review. NPJ Prim Care Respir Med. 2017 Apr 13;27(1):24. doi: 10.1038/s41533-017-0022-1.</citation>
    <PMID>28408742</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1865168</PMID>
  </reference>
  <reference>
    <citation>Ringsberg KC, Wiklund I, Wilhelmsen L. Education of adult patients at an &quot;asthma school&quot;: effects on quality of life, knowledge and need for nursing. Eur Respir J. 1990 Jan;3(1):33-7.</citation>
    <PMID>2311729</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442646
org study id: 2278CE
nct id: NCT04442646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
. 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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: number of exacerbations
time frame: 2 years
description: number of exacerbations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
measure: ER accesses
time frame: 2 years
description: ER accesses in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
measure: number of asthma related hospitalizations
time frame: 2 years
description: number of asthma related hospitalizations in a period of 12 months in asthmatic subjects belonging to experimental group compared to controls.
measure: Asthma control test ACT (0-25)
time frame: 2 years
description: evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
measure: Asthma control questionnaire ACQ (0-6)
time frame: 2 years
description: evaluating asthma symptoms control in Asthma School Group (ASG) compared to Control Group (CG).
measure: St. George Respiratory questionnaire SGRQ (0-100)
time frame: 2 years
description: assessing quality of life in Asthma School Group (ASG) compared to Control Group (CG).
measure: airways and systemic inflammation
time frame: 2 years
description: 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
measure: respiratory function
time frame: 2 years
description: 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).
arm group label: ASG= Asthma School Group, with educational intervention
arm group type: Experimental
description: 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
arm group label: CG= Control Group, With no educational intervention
arm group type: No Intervention
description: Control group will attend control visits every three months.
intervention type: Behavioral
intervention name: multidisciplinary lessons
description: 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
arm group label: ASG= Asthma School Group, with educational intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Antonio Spanevello, Prof
role: Principal Investigator
affiliation: ICS Maugeri
last name: Dina Visca, Prof.
phone: 0331829599
email: dina.visca@icsmaugeri.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
citation: 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.
PMID: 29060130
citation: 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.
PMID: 28408742
citation: 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.
PMID: 1865168
citation: 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.
PMID: 2311729
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No