<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/NCT01729351</url>
  </required_header>
  <id_info>
    <org_study_id>R01911</org_study_id>
    <nct_id>NCT01729351</nct_id>
  </id_info>
  <brief_title>Qvar Therapy in Smoking Asthmatics</brief_title>
  <official_title>Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research in Real-Life Ltd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Research in Real-Life Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF&#xD;
      HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically&#xD;
      fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care&#xD;
      asthma population of current smokers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control proxy incorporating SABA use</measure>
    <time_frame>1 year</time_frame>
    <description>Where control is defined as absence of:&#xD;
(i)Respiratory-related:&#xD;
Hospital attendance or admission A&amp;E attendance, OR Out of hours attendance, OR Out-patient department attendance&#xD;
(ii)GP consultations for lower respiratory tract infection&#xD;
(iii)Prescriptions for acute courses of oral steroids&#xD;
(iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Asthma Exacerbations (ATS Definition)</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as an absence of the the following:&#xD;
Asthma related hospital attendance or admission, OR A&amp;E attendance, OR&#xD;
Use of acute oral steroids.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exacerbation definition based on clinical experience</measure>
    <time_frame>1 year</time_frame>
    <description>Defined as:&#xD;
(i)Respiratory-related:&#xD;
Hospital attendance / admissions OR A&amp;E attendance OR Out of hours consultation OR GP consultation OR (ii) Use of acute oral steroids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma control proxy excluding SABA usage</measure>
    <time_frame>1 year</time_frame>
    <description>Control defined as absence of:&#xD;
(i) Respiratory-related:&#xD;
Hospital attendance or admission A&amp;E attendance, OR Out of hours attendance, OR Out-patient department attendance&#xD;
(ii)GP consultations for lower respiratory tract infection&#xD;
(iii)Prescriptions for acute courses of oral steroids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Success</measure>
    <time_frame>1 year</time_frame>
    <description>Success defined as:&#xD;
No respiratory-related:&#xD;
Hospital attendance or admission A&amp;E attendance, OR Out of hours consultation, OR Out-patient department attendance&#xD;
No GP consultations for lower respiratory tract infection&#xD;
No prescriptions for acute courses of oral steroids&#xD;
No additional or change in therapy:&#xD;
Increased dose of ICS (≥50% increase), and/or Change in ICS and/or Change in delivery device, and/or Use of additional therapy as defined by: LABA, theophylline, leukotriene receptor antagonists (LTRAs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Definite asthma-related hospitalisations</measure>
    <time_frame>1 year</time_frame>
    <description>Hospitalisations coded with an asthma read code</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICS Compliance</measure>
    <time_frame>1 year</time_frame>
    <description>Based on prescription refills</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of oral thrust</measure>
    <time_frame>1 year</time_frame>
    <description>Identified as:&#xD;
Topical oral anti-fungal prescriptions, and / or&#xD;
Coded for oral candidiasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SABA Dose</measure>
    <time_frame>1 year</time_frame>
    <description>Average daily dose of short-acting beta-agonist over the outcome year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Definite and probable asthma-related hospitalisations</measure>
    <time_frame>1 year</time_frame>
    <description>Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code</description>
  </secondary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">7195</enrollment>
  <condition>Asthma</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>IPDI EF HFA-BDP</arm_group_label>
    <description>Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPDI FP</arm_group_label>
    <description>Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPDI NEF HFA-BDP</arm_group_label>
    <description>Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPDA EF HFA-BDP</arm_group_label>
    <description>Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPDA FP</arm_group_label>
    <description>Patients increasing inhaled corticosteroid therapy as FP MDI at the index date</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPDA NEF HFA-BDP</arm_group_label>
    <description>Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are all current smokers ages between 16-70 years with evidence of asthma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 16-70 years&#xD;
&#xD;
          -  Current smokers - explicitly coded in patient records or captured in patient&#xD;
             questionnaires&#xD;
&#xD;
          -  Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at&#xD;
             different points in time during the baseline year ± a diagnostic code for asthma&#xD;
&#xD;
          -  On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1&#xD;
             prescription in addition to IPD prescription)&#xD;
&#xD;
          -  ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded from the analysis if they have:&#xD;
&#xD;
          -  Any chronic respiratory disease other than asthma&#xD;
&#xD;
          -  Are prescribed:&#xD;
&#xD;
          -  Maintenance oral steroid therapy during the baseline year&#xD;
&#xD;
          -  Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD&#xD;
&#xD;
          -  Multiple ICS prescriptions at IPD or immediately before .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Professor Price</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <link>
    <url>http://www.cprd.com</url>
    <description>Clinical Practice Research Database</description>
  </link>
  <reference>
    <citation>Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.</citation>
    <PMID>20692026</PMID>
  </reference>
  <reference>
    <citation>Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.</citation>
    <PMID>21752116</PMID>
  </reference>
  <reference>
    <citation>Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.</citation>
    <PMID>10212105</PMID>
  </reference>
  <reference>
    <citation>Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.</citation>
    <PMID>19067497</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Research in Real-Life Ltd</investigator_affiliation>
    <investigator_full_name>David Price</investigator_full_name>
    <investigator_title>Professor David Price</investigator_title>
  </responsible_party>
  <keyword>Primary Care</keyword>
  <keyword>Particle size</keyword>
  <keyword>beclomethasone dipropionate</keyword>
  <keyword>Asthma Management</keyword>
  <keyword>Maintenance Therapy</keyword>
  <keyword>Metered-Dose Inhaler</keyword>
  <keyword>Smoking</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/NCT01729351
org study id: R01911
nct id: NCT01729351
lead sponsor: 
collaborator: 
has dmc: Yes
To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF
      HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically
      fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care
      asthma population of current smokers.
observational model: Cohort
time perspective: Retrospective
measure: Asthma Control proxy incorporating SABA use
time frame: 1 year
description: Where control is defined as absence of:
(i)Respiratory-related:
Hospital attendance or admission A&E attendance, OR Out of hours attendance, OR Out-patient department attendance
(ii)GP consultations for lower respiratory tract infection
(iii)Prescriptions for acute courses of oral steroids
(iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg
measure: Asthma Exacerbations (ATS Definition)
time frame: 1 year
description: Defined as an absence of the the following:
Asthma related hospital attendance or admission, OR A&E attendance, OR
Use of acute oral steroids.
measure: Exacerbation definition based on clinical experience
time frame: 1 year
description: Defined as:
(i)Respiratory-related:
Hospital attendance / admissions OR A&E attendance OR Out of hours consultation OR GP consultation OR (ii) Use of acute oral steroids
measure: Asthma control proxy excluding SABA usage
time frame: 1 year
description: Control defined as absence of:
(i) Respiratory-related:
Hospital attendance or admission A&E attendance, OR Out of hours attendance, OR Out-patient department attendance
(ii)GP consultations for lower respiratory tract infection
(iii)Prescriptions for acute courses of oral steroids
measure: Treatment Success
time frame: 1 year
description: Success defined as:
No respiratory-related:
Hospital attendance or admission A&E attendance, OR Out of hours consultation, OR Out-patient department attendance
No GP consultations for lower respiratory tract infection
No prescriptions for acute courses of oral steroids
No additional or change in therapy:
Increased dose of ICS (≥50% increase), and/or Change in ICS and/or Change in delivery device, and/or Use of additional therapy as defined by: LABA, theophylline, leukotriene receptor antagonists (LTRAs).
measure: Definite asthma-related hospitalisations
time frame: 1 year
description: Hospitalisations coded with an asthma read code
measure: ICS Compliance
time frame: 1 year
description: Based on prescription refills
measure: Incidence of oral thrust
time frame: 1 year
description: Identified as:
Topical oral anti-fungal prescriptions, and / or
Coded for oral candidiasis
measure: SABA Dose
time frame: 1 year
description: Average daily dose of short-acting beta-agonist over the outcome year
measure: Definite and probable asthma-related hospitalisations
time frame: 1 year
description: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code
arm group label: IPDI EF HFA-BDP
description: Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
arm group label: IPDI FP
description: Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date
arm group label: IPDI NEF HFA-BDP
description: Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date
arm group label: IPDA EF HFA-BDP
description: Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
arm group label: IPDA FP
description: Patients increasing inhaled corticosteroid therapy as FP MDI at the index date
arm group label: IPDA NEF HFA-BDP
description: Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: No
last name: David Professor Price
role: Principal Investigator
affiliation: University of Aberdeen
url: http://www.cprd.com
description: Clinical Practice Research Database
citation: Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.
PMID: 20692026
citation: Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.
PMID: 21752116
citation: Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.
PMID: 10212105
citation: Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.
PMID: 19067497
responsible party type: Principal Investigator
investigator affiliation: Research in Real-Life Ltd
investigator full name: David Price
investigator title: Professor David Price
mesh term: Asthma