<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/NCT01697722</url>
  </required_header>
  <id_info>
    <org_study_id>BA21</org_study_id>
    <nct_id>NCT01697722</nct_id>
  </id_info>
  <brief_title>Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy</brief_title>
  <acronym>QvarvsCombo</acronym>
  <official_title>A Retrospective Evaluation of Effectiveness and Cost-effectiveness of Extrafine HFA-BDP Compared With Combination ICS/LABA Therapy in the Management of Asthma in a Representative Population of UK Primary Care Patients</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>
      This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of&#xD;
      asthma management in patients with evidence of persistent asthma following an increase in&#xD;
      asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)&#xD;
      using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised&#xD;
      metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS&#xD;
      plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone&#xD;
      propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and&#xD;
      BAIs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current asthma guidelines in the UK are underpinned by evidence derived from randomised&#xD;
      controlled trials (RCTs). Although RCT data are considered the gold standard, the patients&#xD;
      recruited to asthma RCTs are estimated to represent less than 10% of the United Kingdom's&#xD;
      (UK's) asthma population. The poor representation of the asthma population is due to a number&#xD;
      of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need&#xD;
      for more representative RCTs and real-life observational studies to inform existing&#xD;
      guidelines and help optimise asthma outcomes.&#xD;
&#xD;
      The fixed combination asthma inhalers, FP/SAL (Seretide) and BUD/FOR (Symbicort) are&#xD;
      indicated for use in asthma when adequate asthma control is not achieved with low/medium dose&#xD;
      ICS therapy and as-needed (prn) reliever therapy (a short-acting beta-agonist [SABA]). Fixed&#xD;
      combination inhalers are also indicated in patients already adequately controlled on separate&#xD;
      ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of&#xD;
      add-on therapies (particularly in the form of combination inhalers) in the early stages of&#xD;
      asthma therapy, even as first-line therapy.&#xD;
&#xD;
      In practice, there is significant pressure (supported by asthma guidelines) to use the least&#xD;
      expensive, effective inhaled therapies available. While the effect of increased use of add-on&#xD;
      and combination therapies in terms of patient benefits remains uncertain, the impact on the&#xD;
      UK's National Health Service (NHS) treatment costs is unequivocal.&#xD;
&#xD;
      Short, randomised trials of the effectiveness of asthma monotherapies have demonstrated that&#xD;
      extrafine HFA-BDP is at least as effective at half the dose as BDP pMDI, and equivalent to&#xD;
      same-dose FP pMDI. There is also evidence to suggest that extrafine HFA-BDP optimises&#xD;
      deposition in the lung and affords greater tolerance of poor coordination of breathing and&#xD;
      inhaler actuation. In addition, one long-term, prospective, randomised, open-labelled trial&#xD;
      comparing extrafine HFA-BDP with BDP over the course of one year demonstrated greater&#xD;
      improvements in symptom-free days and quality of life in the extrafine HFA-BDP treatment&#xD;
      group, at a lower cost per symptom-free day.&#xD;
&#xD;
      The hypothesis for this study, therefore, is that extrafine HFA-BDP may be a suitable, and&#xD;
      cost-effective, alternative to combination therapy (as fixed or separate inhalers) in&#xD;
      children and adults with evidence of persistent asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1991</start_date>
  <completion_date type="Actual">February 2010</completion_date>
  <primary_completion_date type="Actual">June 2007</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>Proxy asthma control</measure>
    <time_frame>One-year outcome period</time_frame>
    <description>No recorded hospital attendance for asthma including admission, Accident &amp; Emergency (A&amp;E) attendance, out of hours attendance or Out-Patient Department (OPD) attendance, AND&#xD;
No prescriptions for oral steroid, AND&#xD;
No consultations, hospital admissions or A&amp;E attendance for lower respiratory tract infections (LRTI) requiring antibiotics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success of therapeutic regimen</measure>
    <time_frame>One-year outcome period</time_frame>
    <description>Defined as the absence of (i) Exacerbation:&#xD;
Unscheduled hospital admissions / A&amp;E attendance for asthma, OR&#xD;
Acute use of oral steroids&#xD;
AND&#xD;
(ii) No consultations, hospital admissions or A&amp;E attendance for LRTI requiring antibiotics&#xD;
AND&#xD;
(iii) No change in therapeutic regimen:&#xD;
Increased dose of ICS, and/or&#xD;
Change in ICS/LABA, and/or&#xD;
Change in delivery device, and/or&#xD;
Use of additional therapy as defined by: theophylline, LTRAs, oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of therapeutic regimen (sensitivity - independent of cost saving)</measure>
    <time_frame>One-year outcome period</time_frame>
    <description>Success: defined as the absence of&#xD;
(i) Exacerbation:&#xD;
Unscheduled hospital admissions / A&amp;E attendance for asthma, OR&#xD;
Acute use of oral steroids&#xD;
AND&#xD;
(ii) No consultations, hospital admissions or A&amp;E attendance for lower respiratory tract infections (LRTI) requiring antibiotics&#xD;
AND&#xD;
(iii) No change in therapeutic regimen:&#xD;
Increased dose of ICS, and/or&#xD;
Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs), oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>average SABA daily dose during outcome year</measure>
    <time_frame>One-year outcome period</time_frame>
    <description>Average daily dose categorised as: 0mcg, &gt;0-100mcg, &gt;100-200mcg, &gt;200-400mcg, &gt;400-800mcg, &gt;800mcg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisations</measure>
    <time_frame>One-year outcome period</time_frame>
    <description>Mean number of asthma and respiratory-related hospitalisations recorded per patient during the outcome year</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">815377</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Step-up as FDC ICS/LABA</arm_group_label>
    <description>ICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Step up as separate therapies</arm_group_label>
    <description>ICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Qvar step-up</arm_group_label>
    <description>ICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extra-fine hydrofluoroalkane-beclometasone dipropionate</intervention_name>
    <description>Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI</description>
    <arm_group_label>Qvar step-up</arm_group_label>
    <other_name>Qvar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICS / LABA via separate pMDI and / or BAI inhalers</intervention_name>
    <description>A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose</description>
    <arm_group_label>Step up as separate therapies</arm_group_label>
    <other_name>ICS+LABA separates</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA,&#xD;
        BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either:&#xD;
&#xD;
        (i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination&#xD;
        therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent&#xD;
        dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no&#xD;
        increase in daily BDP-equivalent dose).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged: 4-60 years:&#xD;
&#xD;
               -  Paediatric cohort (aged 4-11 years), and&#xD;
&#xD;
               -  Adult cohort (aged 12-60 years)&#xD;
&#xD;
               -  Aged 61-80 years and never smoked for an additional elderly cohort;&#xD;
&#xD;
          -  Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma&#xD;
             prescriptions, including one ICS prescription, at different points in time during the&#xD;
             year prior to IPD (the baseline year)&#xD;
&#xD;
          -  Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to&#xD;
             IPD, and at least 1 other asthma prescription during the same period&#xD;
&#xD;
          -  Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at&#xD;
             least one year of UTS outcome data (following the IPD).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any&#xD;
             time&#xD;
&#xD;
          -  had a diagnostic read code for chronic respiratory disease at any time (other than&#xD;
             asthma)&#xD;
&#xD;
          -  any patients receiving a combination inhaler in addition to their separate ICS inhaler&#xD;
             in the baseline year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Price, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Company Director</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alison Chisholm, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Research Project Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Practice Research Database</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.optimumpatientcare.org</url>
    <description>Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)</description>
  </link>
  <reference>
    <citation>Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger &quot;real life&quot; population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.</citation>
    <PMID>15672843</PMID>
  </reference>
  <reference>
    <citation>Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.</citation>
    <PMID>17113277</PMID>
  </reference>
  <reference>
    <citation>Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.</citation>
    <PMID>16275363</PMID>
  </reference>
  <reference>
    <citation>Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, 2007. (Accessed March 2008, at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf</citation>
  </reference>
  <reference>
    <citation>Aubier M, Wettenger R, Gans SJ. Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma. Respir Med. 2001 Mar;95(3):212-20. doi: 10.1053/rmed.2000.1025.</citation>
    <PMID>11266239</PMID>
  </reference>
  <reference>
    <citation>Fairfax A, Hall I, Spelman R. A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate. Ann Allergy Asthma Immunol. 2001 May;86(5):575-82. doi: 10.1016/S1081-1206(10)62907-9.</citation>
    <PMID>11379810</PMID>
  </reference>
  <reference>
    <citation>Lasserson TJ, Cates CK, Jones AB, Steele EH, White J. Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.</citation>
    <PMID>16625634</PMID>
  </reference>
  <reference>
    <citation>Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.</citation>
    <PMID>10027430</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 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>Asthma management</keyword>
  <keyword>Inhaled corticosteroids</keyword>
  <keyword>Extra-fine hydrofluoroalkane</keyword>
  <keyword>Long-acting beta-agonist</keyword>
  <keyword>Fixed-dose combination therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Beclomethasone</mesh_term>
  </intervention_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/NCT01697722
org study id: BA21
nct id: NCT01697722
lead sponsor: 
collaborator: 
has dmc: Yes
This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of
      asthma management in patients with evidence of persistent asthma following an increase in
      asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS)
      using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised
      metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS
      plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone
      propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and
      BAIs.
Current asthma guidelines in the UK are underpinned by evidence derived from randomised
      controlled trials (RCTs). Although RCT data are considered the gold standard, the patients
      recruited to asthma RCTs are estimated to represent less than 10% of the United Kingdom's
      (UK's) asthma population. The poor representation of the asthma population is due to a number
      of factors, such as tightly-controlled inclusion criteria for RCTs. There is therefore a need
      for more representative RCTs and real-life observational studies to inform existing
      guidelines and help optimise asthma outcomes.

      The fixed combination asthma inhalers, FP/SAL (Seretide) and BUD/FOR (Symbicort) are
      indicated for use in asthma when adequate asthma control is not achieved with low/medium dose
      ICS therapy and as-needed (prn) reliever therapy (a short-acting beta-agonist [SABA]). Fixed
      combination inhalers are also indicated in patients already adequately controlled on separate
      ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of
      add-on therapies (particularly in the form of combination inhalers) in the early stages of
      asthma therapy, even as first-line therapy.

      In practice, there is significant pressure (supported by asthma guidelines) to use the least
      expensive, effective inhaled therapies available. While the effect of increased use of add-on
      and combination therapies in terms of patient benefits remains uncertain, the impact on the
      UK's National Health Service (NHS) treatment costs is unequivocal.

      Short, randomised trials of the effectiveness of asthma monotherapies have demonstrated that
      extrafine HFA-BDP is at least as effective at half the dose as BDP pMDI, and equivalent to
      same-dose FP pMDI. There is also evidence to suggest that extrafine HFA-BDP optimises
      deposition in the lung and affords greater tolerance of poor coordination of breathing and
      inhaler actuation. In addition, one long-term, prospective, randomised, open-labelled trial
      comparing extrafine HFA-BDP with BDP over the course of one year demonstrated greater
      improvements in symptom-free days and quality of life in the extrafine HFA-BDP treatment
      group, at a lower cost per symptom-free day.

      The hypothesis for this study, therefore, is that extrafine HFA-BDP may be a suitable, and
      cost-effective, alternative to combination therapy (as fixed or separate inhalers) in
      children and adults with evidence of persistent asthma.
observational model: Cohort
time perspective: Retrospective
measure: Proxy asthma control
time frame: One-year outcome period
description: No recorded hospital attendance for asthma including admission, Accident & Emergency (A&E) attendance, out of hours attendance or Out-Patient Department (OPD) attendance, AND
No prescriptions for oral steroid, AND
No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics
measure: Success of therapeutic regimen
time frame: One-year outcome period
description: Defined as the absence of (i) Exacerbation:
Unscheduled hospital admissions / A&E attendance for asthma, OR
Acute use of oral steroids
AND
(ii) No consultations, hospital admissions or A&E attendance for LRTI requiring antibiotics
AND
(iii) No change in therapeutic regimen:
Increased dose of ICS, and/or
Change in ICS/LABA, and/or
Change in delivery device, and/or
Use of additional therapy as defined by: theophylline, LTRAs, oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).
measure: Success of therapeutic regimen (sensitivity - independent of cost saving)
time frame: One-year outcome period
description: Success: defined as the absence of
(i) Exacerbation:
Unscheduled hospital admissions / A&E attendance for asthma, OR
Acute use of oral steroids
AND
(ii) No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics
AND
(iii) No change in therapeutic regimen:
Increased dose of ICS, and/or
Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs), oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).
measure: average SABA daily dose during outcome year
time frame: One-year outcome period
description: Average daily dose categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg).
measure: Hospitalisations
time frame: One-year outcome period
description: Mean number of asthma and respiratory-related hospitalisations recorded per patient during the outcome year
arm group label: Step-up as FDC ICS/LABA
description: ICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).
arm group label: Step up as separate therapies
description: ICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).
arm group label: Qvar step-up
description: ICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate
intervention type: Drug
intervention name: Extra-fine hydrofluoroalkane-beclometasone dipropionate
description: Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI
arm group label: Qvar step-up
other name: Qvar
intervention type: Drug
intervention name: ICS / LABA via separate pMDI and / or BAI inhalers
description: A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose
arm group label: Step up as separate therapies
other name: ICS+LABA separates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 80 Years
healthy volunteers: No
last name: David Price, Prof. MD
role: Principal Investigator
affiliation: Company Director
last name: Alison Chisholm, MSc
role: Study Director
affiliation: Research Project Director
facility: 
country: United Kingdom
url: http://www.optimumpatientcare.org
description: Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)
citation: Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.
PMID: 15672843
citation: Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.
PMID: 17113277
citation: Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.
PMID: 16275363
citation: Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, 2007. (Accessed March 2008, at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf
citation: Aubier M, Wettenger R, Gans SJ. Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma. Respir Med. 2001 Mar;95(3):212-20. doi: 10.1053/rmed.2000.1025.
PMID: 11266239
citation: Fairfax A, Hall I, Spelman R. A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate. Ann Allergy Asthma Immunol. 2001 May;86(5):575-82. doi: 10.1016/S1081-1206(10)62907-9.
PMID: 11379810
citation: Lasserson TJ, Cates CK, Jones AB, Steele EH, White J. Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.
PMID: 16625634
citation: Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.
PMID: 10027430
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
mesh term: Beclomethasone