<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/NCT04448262</url>
  </required_header>
  <id_info>
    <org_study_id>2290 CE</org_study_id>
    <nct_id>NCT04448262</nct_id>
  </id_info>
  <brief_title>Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity</brief_title>
  <official_title>Bronchial Asthma and Diabetes: Impact on Bronchial Inflammation and Exercise Capacity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Galmarini Hospital, Tradate</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 2 diabetes is the most common form of diabetes and according to several studies, even&#xD;
      lung can represent another target of the diabetic disease. Asthmatic patients often show&#xD;
      comorbidities and obesity is one of the main.Several studies in literature suggest that&#xD;
      patients with higher Body Mass Index (i.e. overweight and obese) have a greater risk of&#xD;
      developing asthma compared to normal weight subjects. Considering inflammation, asthma is&#xD;
      usually characterized by an increase of eosinophils in the airways and by a Th2 type&#xD;
      inflammation, while a immunological type Th1 switch systemically characterizes diabetes. Even&#xD;
      asthmatic patients, especially if diabetic, might have an increase of glucose in their&#xD;
      airways, that could favourite or feed an inflammatory/infective state. Up to-day there are&#xD;
      not in literature studies that have investigated the airways inflammatory pattern and the&#xD;
      exercise capacity in relation to functional characteristics in diabetic patients affected by&#xD;
      asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The basic therapy for asthma treatment involves the use of corticosteroids that can lead to&#xD;
      the development of glucose intolerance and to the onset of diabetes. Moreover, several works&#xD;
      in literature highlight the fact that patients with diagnosis of both asthma and diabetes&#xD;
      have a scarcer glycaemic control, a reduced life expectancy, and a higher risk of pneumonia&#xD;
      when compared to patients with only asthma or only diabetes.&#xD;
&#xD;
      However, in the last years the evaluation of the inflammatory patterns in asthmatic patients&#xD;
      has revealed a heterogeneity of the inflammation, with patients characterized by neutrophilic&#xD;
      phenotype, mixed granulocytic or without a well-defined inflammatory component&#xD;
      (pauci-granulocytic phenotype).On the other side, a immunological type Th1 switch&#xD;
      systemically characterizes diabetes. The impact of diabetes, therefore, as a comorbidity in&#xD;
      asthmatic patients could influence the inflammatory status of airways. Moreover, studies have&#xD;
      reported that glucose is higher in the airways of subjects affected by chronic obstructive&#xD;
      pulmonary disease and it correlates with bacterial and viral load compared to healthy&#xD;
      controls. Even asthmatic patients, especially if diabetic, might have an increase of glucose&#xD;
      in their airways, that could favourite or feed an inflammatory/infective state. Although&#xD;
      physical exercise is able to reduce the level of systemic inflammation, improving asthma&#xD;
      symptoms and glycaemic control, it is well known that asthmatic and diabetic patients tend to&#xD;
      lead a more sedentary life style compared to healthy subjects.A limiting factor that bonds&#xD;
      the two pathologies is obesity, since the gain of weight causes exacerbation of respiratory&#xD;
      symptoms, resulting in lower effort tolerance.&#xD;
&#xD;
      Up to-day there are not in literature studies that have investigated the airways inflammatory&#xD;
      pattern and the exercise capacity in relation to functional characteristics in diabetic&#xD;
      patients affected by asthma.&#xD;
&#xD;
      Aim of the study is to characterize the airways inflammatory pattern of patients affected by&#xD;
      bronchial asthma, patients affected by type II diabetes and patients with concomitant&#xD;
      diagnosis of asthma and diabetes by using induced sputum. Secondary objective is to&#xD;
      characterize the exercise capacity in relation to the functional and anthropometric&#xD;
      characteristics of patients with diabetes, with asthma and diabetes, compared to patients&#xD;
      with only asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>inflammatory cells</measure>
    <time_frame>baseline</time_frame>
    <description>macrophages%,neutrophils%, eosinophils%, lymphocytes%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Expiratory muscles strength</measure>
    <time_frame>baseline</time_frame>
    <description>Maximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional capacity of exercise</measure>
    <time_frame>baseline</time_frame>
    <description>6 minutes walking test-6MWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnoea and muscular fatigue</measure>
    <time_frame>baseline</time_frame>
    <description>Dyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peripheral muscle strength</measure>
    <time_frame>baseline</time_frame>
    <description>Five Sit to Stand Test-5STS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related Quality of life</measure>
    <time_frame>baseline</time_frame>
    <description>St. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceived Health state</measure>
    <time_frame>baseline</time_frame>
    <description>Chronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Asthma</condition>
  <condition>Diabete Type 2</condition>
  <arm_group>
    <arm_group_label>G1 Asthma</arm_group_label>
    <description>Diagnosis of bronchial asthma according to the Global Initiative for Asthma (GINA) 2018 guideline Clinical stability of asthmatic disease Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G2 Diabetes</arm_group_label>
    <description>Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c &lt; 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G3 Asthma plus diabetes</arm_group_label>
    <description>Concomitant diagnosis of bronchial asthma according to the GINA 2018 guideline, Clinical stability of asthmatic disease and Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c &lt; 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection</intervention_name>
    <description>collection of data about bronchial and systemic inflammation, quality of life, lung function</description>
    <arm_group_label>G1 Asthma</arm_group_label>
    <arm_group_label>G2 Diabetes</arm_group_label>
    <arm_group_label>G3 Asthma plus diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Asthmatic patients will be evaluated and enrolled during outpatients follow-up visits at&#xD;
        the ICS Institute Maugeri of Tradate, type II diabetic patients at the Galmarini Hospital&#xD;
        of Tradate, while patients with concomitant diagnosis of asthma and type II diabetes will&#xD;
        be evaluated and enrolled and enrolled in both the two structures.&#xD;
&#xD;
        20 patients per group will be the sample size&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of bronchial asthma according to the GINA 2018 guideline&#xD;
&#xD;
          -  Clinical stability of asthmatic disease&#xD;
&#xD;
          -  Diagnosis of Type II diabetes according to the last Italian guidelines (1) and HbA1c &lt;&#xD;
             9%, 54-75mmol/mol&#xD;
&#xD;
          -  Concomitant diagnosis of bronchial asthma (12) and diabetes according to the described&#xD;
             guidelines&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Not-smokers, smokers or ex-smokers with pack/year ≤10&#xD;
&#xD;
          -  Patients able to collaborate in the required procedures and who have signed the&#xD;
             informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Bronchial asthma and/or diabetes with scarce clinical control.&#xD;
&#xD;
          -  Diagnosis of cognitive impairment&#xD;
&#xD;
          -  Not able to carry out study procedures&#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>Study Director</role>
    <affiliation>ICS Maugeri</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituti Clinici Maugeri Pneumologia</name>
      <address>
        <city>Tradate</city>
        <state>Lombardia</state>
        <zip>21049</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Vracko R, Thorning D, Huang TW. Basal lamina of alveolar epithelium and capillaries: quantitative changes with aging and in diabetes mellitus. Am Rev Respir Dis. 1979 Nov;120(5):973-83. doi: 10.1164/arrd.1979.120.5.973.</citation>
    <PMID>507532</PMID>
  </reference>
  <reference>
    <citation>Visca D, Pignatti P, Spanevello A, Lucini E, La Rocca E. Relationship between diabetes and respiratory diseases-Clinical and therapeutic aspects. Pharmacol Res. 2018 Nov;137:230-235. doi: 10.1016/j.phrs.2018.10.008. Epub 2018 Oct 9.</citation>
    <PMID>30312663</PMID>
  </reference>
  <reference>
    <citation>Cardet JC, Ash S, Kusa T, Camargo CA Jr, Israel E. Insulin resistance modifies the association between obesity and current asthma in adults. Eur Respir J. 2016 Aug;48(2):403-10. doi: 10.1183/13993003.00246-2016. Epub 2016 Apr 21.</citation>
    <PMID>27103388</PMID>
  </reference>
  <reference>
    <citation>Mallia P, Webber J, Gill SK, Trujillo-Torralbo MB, Calderazzo MA, Finney L, Bakhsoliani E, Farne H, Singanayagam A, Footitt J, Hewitt R, Kebadze T, Aniscenko J, Padmanaban V, Molyneaux PL, Adcock IM, Barnes PJ, Ito K, Elkin SL, Kon OM, Cookson WO, Moffat MF, Johnston SL, Tregoning JS. Role of airway glucose in bacterial infections in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2018 Sep;142(3):815-823.e6. doi: 10.1016/j.jaci.2017.10.017. Epub 2018 Jan 5.</citation>
    <PMID>29310905</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>April 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eosinophils, symptoms, lung</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04448262
org study id: 2290 CE
nct id: NCT04448262
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Type 2 diabetes is the most common form of diabetes and according to several studies, even
      lung can represent another target of the diabetic disease. Asthmatic patients often show
      comorbidities and obesity is one of the main.Several studies in literature suggest that
      patients with higher Body Mass Index (i.e. overweight and obese) have a greater risk of
      developing asthma compared to normal weight subjects. Considering inflammation, asthma is
      usually characterized by an increase of eosinophils in the airways and by a Th2 type
      inflammation, while a immunological type Th1 switch systemically characterizes diabetes. Even
      asthmatic patients, especially if diabetic, might have an increase of glucose in their
      airways, that could favourite or feed an inflammatory/infective state. Up to-day there are
      not in literature studies that have investigated the airways inflammatory pattern and the
      exercise capacity in relation to functional characteristics in diabetic patients affected by
      asthma.
The basic therapy for asthma treatment involves the use of corticosteroids that can lead to
      the development of glucose intolerance and to the onset of diabetes. Moreover, several works
      in literature highlight the fact that patients with diagnosis of both asthma and diabetes
      have a scarcer glycaemic control, a reduced life expectancy, and a higher risk of pneumonia
      when compared to patients with only asthma or only diabetes.

      However, in the last years the evaluation of the inflammatory patterns in asthmatic patients
      has revealed a heterogeneity of the inflammation, with patients characterized by neutrophilic
      phenotype, mixed granulocytic or without a well-defined inflammatory component
      (pauci-granulocytic phenotype).On the other side, a immunological type Th1 switch
      systemically characterizes diabetes. The impact of diabetes, therefore, as a comorbidity in
      asthmatic patients could influence the inflammatory status of airways. Moreover, studies have
      reported that glucose is higher in the airways of subjects affected by chronic obstructive
      pulmonary disease and it correlates with bacterial and viral load compared to healthy
      controls. Even asthmatic patients, especially if diabetic, might have an increase of glucose
      in their airways, that could favourite or feed an inflammatory/infective state. Although
      physical exercise is able to reduce the level of systemic inflammation, improving asthma
      symptoms and glycaemic control, it is well known that asthmatic and diabetic patients tend to
      lead a more sedentary life style compared to healthy subjects.A limiting factor that bonds
      the two pathologies is obesity, since the gain of weight causes exacerbation of respiratory
      symptoms, resulting in lower effort tolerance.

      Up to-day there are not in literature studies that have investigated the airways inflammatory
      pattern and the exercise capacity in relation to functional characteristics in diabetic
      patients affected by asthma.

      Aim of the study is to characterize the airways inflammatory pattern of patients affected by
      bronchial asthma, patients affected by type II diabetes and patients with concomitant
      diagnosis of asthma and diabetes by using induced sputum. Secondary objective is to
      characterize the exercise capacity in relation to the functional and anthropometric
      characteristics of patients with diabetes, with asthma and diabetes, compared to patients
      with only asthma.
observational model: Cohort
time perspective: Prospective
measure: inflammatory cells
time frame: baseline
description: macrophages%,neutrophils%, eosinophils%, lymphocytes%
measure: Expiratory muscles strength
time frame: baseline
description: Maximal inspiratory pressure -MIP, Maximal expiratory pressure -MEP
measure: Functional capacity of exercise
time frame: baseline
description: 6 minutes walking test-6MWT
measure: Dyspnoea and muscular fatigue
time frame: baseline
description: Dyspnoea and muscle fatigue measured with Modified Borg Scale (0-10, where 0 is better)
measure: peripheral muscle strength
time frame: baseline
description: Five Sit to Stand Test-5STS
measure: Health related Quality of life
time frame: baseline
description: St. George Respiratory Questionnaire-SGRQ, scores range from 0 to 100, with higher scores indicating more limitations
measure: perceived Health state
time frame: baseline
description: Chronic Obstructive Pulmonary Disease Assessment test-CAT, Scores range from 0 to 40, with higher scores indicating worse health state
arm group label: G1 Asthma
description: Diagnosis of bronchial asthma according to the Global Initiative for Asthma (GINA) 2018 guideline Clinical stability of asthmatic disease Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10
arm group label: G2 Diabetes
description: Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c < 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10
arm group label: G3 Asthma plus diabetes
description: Concomitant diagnosis of bronchial asthma according to the GINA 2018 guideline, Clinical stability of asthmatic disease and Diagnosis of Type II diabetes according to the last Italian guidelines and HbA1c < 9%, 54-75mmol/mol Age ≥18 years Not-smokers, smokers or ex-smokers with pack/year ≤10
intervention type: Other
intervention name: data collection
description: collection of data about bronchial and systemic inflammation, quality of life, lung function
arm group label: G1 Asthma
arm group label: G2 Diabetes
arm group label: G3 Asthma plus diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Antonio Spanevello, Prof
role: Study Director
affiliation: ICS Maugeri
facility: 
country: Italy
citation: Vracko R, Thorning D, Huang TW. Basal lamina of alveolar epithelium and capillaries: quantitative changes with aging and in diabetes mellitus. Am Rev Respir Dis. 1979 Nov;120(5):973-83. doi: 10.1164/arrd.1979.120.5.973.
PMID: 507532
citation: Visca D, Pignatti P, Spanevello A, Lucini E, La Rocca E. Relationship between diabetes and respiratory diseases-Clinical and therapeutic aspects. Pharmacol Res. 2018 Nov;137:230-235. doi: 10.1016/j.phrs.2018.10.008. Epub 2018 Oct 9.
PMID: 30312663
citation: Cardet JC, Ash S, Kusa T, Camargo CA Jr, Israel E. Insulin resistance modifies the association between obesity and current asthma in adults. Eur Respir J. 2016 Aug;48(2):403-10. doi: 10.1183/13993003.00246-2016. Epub 2016 Apr 21.
PMID: 27103388
citation: Mallia P, Webber J, Gill SK, Trujillo-Torralbo MB, Calderazzo MA, Finney L, Bakhsoliani E, Farne H, Singanayagam A, Footitt J, Hewitt R, Kebadze T, Aniscenko J, Padmanaban V, Molyneaux PL, Adcock IM, Barnes PJ, Ito K, Elkin SL, Kon OM, Cookson WO, Moffat MF, Johnston SL, Tregoning JS. Role of airway glucose in bacterial infections in patients with chronic obstructive pulmonary disease. J Allergy Clin Immunol. 2018 Sep;142(3):815-823.e6. doi: 10.1016/j.jaci.2017.10.017. Epub 2018 Jan 5.
PMID: 29310905
responsible party type: Sponsor
mesh term: Asthma
mesh term: Diabetes Mellitus, Type 2
mesh term: Inflammation
sharing ipd: Undecided