<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/NCT01708486</url>
  </required_header>
  <id_info>
    <org_study_id>2011-FLUSAL-EL-24</org_study_id>
    <nct_id>NCT01708486</nct_id>
  </id_info>
  <brief_title>BALLOON (Corticosteroid/laBA inhaLers in adoLescents' Asthma: Assessment Of Patients satisfactiON) Study</brief_title>
  <acronym>BALLOON</acronym>
  <official_title>Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elpen Pharmaceutical Co. Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elpen Pharmaceutical Co. Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients' satisfaction with their asthma medication devices is usually decided by using&#xD;
      properly designed questionnaires. These questionnaires are to be used to evaluate patients'&#xD;
      opinion, which is considered very important for the selection of a device.&#xD;
&#xD;
      The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed&#xD;
      to assess the patient opinion regarding the satisfaction and usability of the inhalers&#xD;
      irrespectively of the drug used. It consists of 10 question each with 5 possible responses on&#xD;
      a 5-point Likert scale scored from 5 to 1, respectively. The total score can range between 10&#xD;
      and 50. The higher the score, the higher the feeling of patient satisfaction from the&#xD;
      inhaler.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood and adolescents' asthma is the most common chronic disease of childhood and is the&#xD;
      major cause of absenteeism from school students. To deal with the disease often require&#xD;
      hospitalization, fortunately, very rare enough to be life-threatening. Since the mid-80s had&#xD;
      clearly expressed by several centers to observe the rising incidence of the disease. The next&#xD;
      year observation was confirmed many times. Childhood asthma has been characterized as a&#xD;
      disease of modern Western civilization. It affects a large proportion of the child population&#xD;
      and seems to take longer epidemic character.&#xD;
&#xD;
      From studies carried out recently in Greece found that children of school age asthmatic type&#xD;
      symptoms during the past 12 months appear to 5-10% of pupils. The rates are doubled when the&#xD;
      question is not limited to the last 12 months. Also in a study involving 2133 children aged 7&#xD;
      and 18 years, the prevalence of asthma was 7.7% and 4.7% (at the age of 7 and 18 years&#xD;
      respectively) and chronic asthma 19.6% and 26.3% (at the age of 7 and 18 years,&#xD;
      respectively), while over half of the children (58.2%) with early asthma (asthma diagnosed&#xD;
      before age 7) had no symptoms at the age of 7. At the age of 18 still had symptoms for 7.6%&#xD;
      of children with early asthma and 48.2% of children who developed asthma between 7-18 years&#xD;
      (6.7% of study participants).&#xD;
&#xD;
      For the onset of childhood asthma synergize two factors: genetic, ie heredity, and&#xD;
      environmental, that is the environment in which we live. There is a predisposition for the&#xD;
      disease and the environment favors the onset. So to increase the prevalence implicated: a)&#xD;
      genetic predisposition, b) the method of construction of houses, c) smoking (assets -&#xD;
      liabilities), c) indoor pollution, d) atmospheric pollution, e) the modern way of eating and&#xD;
      clothing and f) preventing illness by a large number of serious infections due to the&#xD;
      widespread use of vaccines.Most asthma medications are administered using suitable inhalers.&#xD;
      There are various types of devices that facilitate the administration of inhaled medications&#xD;
      in young children. The correct use of inhalational devices is very important for the&#xD;
      treatment of asthma. If the patient does not understand the instructions, the drug is&#xD;
      deposited satisfactorily lungs, ie organ must act, so there is no remission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feeling of satisfaction with inhalation devices in asthmatic children</measure>
    <time_frame>2 months</time_frame>
    <description>FSI-10 questionnaire rating per inhalation device. FSI-10 consists of 10 questions with 5 possible responses on a 5-point Likert scale scored from 5 to 1,respectively. The total score can range between 10 and 50. The higher the score, the higher the feeling of patient satisfaction from the inhaler.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FSI-10 questionnaire ratings' comparison for inhalation devices</measure>
    <time_frame>2 months</time_frame>
    <description>The total score will be compared among devices. Each question grating will be also compared among devices.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Adolescents' with asthma using inhalation devices</arm_group_label>
    <description>Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        180 asthmatic adolescents (60 per device) aged 12-18 years using their inhalation device at&#xD;
        least one month before study enrolment. This will be a real-life, regular clinical practice&#xD;
        assesment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with history of asthma or newly diagnosed&#xD;
&#xD;
          -  Patient who are on their inhalation device treatment at least one month before study&#xD;
             enrolment&#xD;
&#xD;
          -  Patients Male and Female&#xD;
&#xD;
          -  Patients' Age: 12-18 years&#xD;
&#xD;
          -  Patients who are familiar with their inhalation device&#xD;
&#xD;
          -  Patients with correct use of any individual inhalation device&#xD;
&#xD;
          -  Patients who will follow all study procedures&#xD;
&#xD;
          -  Patients who agree to record their evaluation in written by filling in the FSI-10&#xD;
             questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who are on their inhalation device treatment less than one month before study&#xD;
             enrolment&#xD;
&#xD;
          -  Patients' Age: &lt;12, &gt;18 years&#xD;
&#xD;
          -  Patients with incorrect use of any individual inhalation device&#xD;
&#xD;
          -  Patients with no sufficient treatment compliance&#xD;
&#xD;
          -  Patients with no sufficient study procedures' compliance&#xD;
&#xD;
          -  Patients who do not agree to record their evaluation in written by filling in the&#xD;
             FSI-10 questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ch Hatzimihael, MD Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Democretion University of Alexandroupolis, Pediatric Department, Thrace, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emm Paraskakis, MD, Ass Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Demokretion University of Alexandroupolis, Pediatric Department, Thrace, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ath Kaditis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Poly Panayotopoulou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dimos Gidaris, MD Pulmonologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hippokration Hospital of Thessaloniki, Scientific collaborator</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Anthrakopoulos, MD, Associate Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Rio, Patras, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hippokrateion University Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>http://www.mednet.gr/archives/2011-2/pdf/257.pdf</url>
    <description>Reliability of the FSI-10 questionnaire for the assessmentof the usability of drug inhalers in Greek patients</description>
  </link>
  <reference>
    <citation>Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. doi: 10.1183/09031936.03.00097503.</citation>
    <PMID>12882462</PMID>
  </reference>
  <reference>
    <citation>Kozma CM, Slaton TL, Monz BU, Hodder R, Reese PR. Development and validation of a patient satisfaction and preference questionnaire for inhalation devices. Treat Respir Med. 2005;4(1):41-52. doi: 10.2165/00151829-200504010-00005.</citation>
    <PMID>15725049</PMID>
  </reference>
  <reference>
    <citation>Perpina Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martinez Gonzalez del Rio J, Duce F, Munoz Cabrera L. [Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. Arch Bronconeumol. 2008 Jul;44(7):346-52. Spanish.</citation>
    <PMID>18727886</PMID>
  </reference>
  <reference>
    <citation>Epstein S, Maidenberg A, Hallett D, Khan K, Chapman KR. Patient handling of a dry-powder inhaler in clinical practice. Chest. 2001 Nov;120(5):1480-4. doi: 10.1378/chest.120.5.1480.</citation>
    <PMID>11713123</PMID>
  </reference>
  <reference>
    <citation>van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.</citation>
    <PMID>10596686</PMID>
  </reference>
  <reference>
    <citation>Reliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients. N. Grekas, A. Athanassiou, C. Iskos, D. Panagiotakos, A. Papataxiarchou, O. Porichi. Arch Hellen Med, 28(2), March-April 2011, 257-260.</citation>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>Dry Powder Inhalers</keyword>
  <keyword>FSI-10 questionnaire</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <!-- 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/NCT01708486
org study id: 2011-FLUSAL-EL-24
nct id: NCT01708486
lead sponsor: 
has dmc: No
Patients' satisfaction with their asthma medication devices is usually decided by using
      properly designed questionnaires. These questionnaires are to be used to evaluate patients'
      opinion, which is considered very important for the selection of a device.

      The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed
      to assess the patient opinion regarding the satisfaction and usability of the inhalers
      irrespectively of the drug used. It consists of 10 question each with 5 possible responses on
      a 5-point Likert scale scored from 5 to 1, respectively. The total score can range between 10
      and 50. The higher the score, the higher the feeling of patient satisfaction from the
      inhaler.
Childhood and adolescents' asthma is the most common chronic disease of childhood and is the
      major cause of absenteeism from school students. To deal with the disease often require
      hospitalization, fortunately, very rare enough to be life-threatening. Since the mid-80s had
      clearly expressed by several centers to observe the rising incidence of the disease. The next
      year observation was confirmed many times. Childhood asthma has been characterized as a
      disease of modern Western civilization. It affects a large proportion of the child population
      and seems to take longer epidemic character.

      From studies carried out recently in Greece found that children of school age asthmatic type
      symptoms during the past 12 months appear to 5-10% of pupils. The rates are doubled when the
      question is not limited to the last 12 months. Also in a study involving 2133 children aged 7
      and 18 years, the prevalence of asthma was 7.7% and 4.7% (at the age of 7 and 18 years
      respectively) and chronic asthma 19.6% and 26.3% (at the age of 7 and 18 years,
      respectively), while over half of the children (58.2%) with early asthma (asthma diagnosed
      before age 7) had no symptoms at the age of 7. At the age of 18 still had symptoms for 7.6%
      of children with early asthma and 48.2% of children who developed asthma between 7-18 years
      (6.7% of study participants).

      For the onset of childhood asthma synergize two factors: genetic, ie heredity, and
      environmental, that is the environment in which we live. There is a predisposition for the
      disease and the environment favors the onset. So to increase the prevalence implicated: a)
      genetic predisposition, b) the method of construction of houses, c) smoking (assets -
      liabilities), c) indoor pollution, d) atmospheric pollution, e) the modern way of eating and
      clothing and f) preventing illness by a large number of serious infections due to the
      widespread use of vaccines.Most asthma medications are administered using suitable inhalers.
      There are various types of devices that facilitate the administration of inhaled medications
      in young children. The correct use of inhalational devices is very important for the
      treatment of asthma. If the patient does not understand the instructions, the drug is
      deposited satisfactorily lungs, ie organ must act, so there is no remission.
time perspective: Prospective
measure: Feeling of satisfaction with inhalation devices in asthmatic children
time frame: 2 months
description: FSI-10 questionnaire rating per inhalation device. FSI-10 consists of 10 questions with 5 possible responses on a 5-point Likert scale scored from 5 to 1,respectively. The total score can range between 10 and 50. The higher the score, the higher the feeling of patient satisfaction from the inhaler.
measure: FSI-10 questionnaire ratings' comparison for inhalation devices
time frame: 2 months
description: The total score will be compared among devices. Each question grating will be also compared among devices.
arm group label: Adolescents' with asthma using inhalation devices
description: Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Ch Hatzimihael, MD Professor
role: Principal Investigator
affiliation: Democretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
last name: Emm Paraskakis, MD, Ass Professor
role: Principal Investigator
affiliation: Demokretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
last name: Ath Kaditis, MD
role: Principal Investigator
affiliation: Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department
last name: Poly Panayotopoulou, MD
role: Principal Investigator
affiliation: Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department
last name: Dimos Gidaris, MD Pulmonologist
role: Principal Investigator
affiliation: Hippokration Hospital of Thessaloniki, Scientific collaborator
last name: Michael Anthrakopoulos, MD, Associate Professor
role: Principal Investigator
affiliation: University Hospital of Rio, Patras, Greece
facility: 
country: Greece
url: http://www.mednet.gr/archives/2011-2/pdf/257.pdf
description: Reliability of the FSI-10 questionnaire for the assessmentof the usability of drug inhalers in Greek patients
citation: Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. doi: 10.1183/09031936.03.00097503.
PMID: 12882462
citation: Kozma CM, Slaton TL, Monz BU, Hodder R, Reese PR. Development and validation of a patient satisfaction and preference questionnaire for inhalation devices. Treat Respir Med. 2005;4(1):41-52. doi: 10.2165/00151829-200504010-00005.
PMID: 15725049
citation: Perpina Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martinez Gonzalez del Rio J, Duce F, Munoz Cabrera L. [Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. Arch Bronconeumol. 2008 Jul;44(7):346-52. Spanish.
PMID: 18727886
citation: Epstein S, Maidenberg A, Hallett D, Khan K, Chapman KR. Patient handling of a dry-powder inhaler in clinical practice. Chest. 2001 Nov;120(5):1480-4. doi: 10.1378/chest.120.5.1480.
PMID: 11713123
citation: van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.
PMID: 10596686
citation: Reliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients. N. Grekas, A. Athanassiou, C. Iskos, D. Panagiotakos, A. Papataxiarchou, O. Porichi. Arch Hellen Med, 28(2), March-April 2011, 257-260.
responsible party type: Sponsor
mesh term: Asthma