Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management (QvarAsthma)

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by:
Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01141439
First received: June 9, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).


Condition Intervention
Asthma
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Drug: Fluticasone propionate
Drug: Beclomethasone dipropionate
Drug: fluticasone propionate
Drug: Chlorofluorocarbon beclomethasone dipropionate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population

Resource links provided by NLM:


Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:
  • Proxy asthma control [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Primary composite measure asthma control defined as:

    • 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.


Secondary Outcome Measures:
  • Revised asthma control [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    A revised definition of proxy asthma control for sensitivity analysis was defined as:

    • No recorded hospital attendance for asthma including admission, A&E attendance, out of hours attendance or 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
    • Average daily prescribed dose of salbutamol of no more than 200mcg and terbutaline 500mcg.

  • Disaggregated components of the primary control outcome [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    • Hospital admissions for asthma
    • Consultations and hospital attendances for LRTI requiring antibiotics
    • Prescriptions for oral steroids
    • SABA use

  • Time to the first asthma exacerbation [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Where an exacerbation is defined as:

    • An occurrence of unscheduled hospital admission/A&E attendances for asthma AND/OR
    • Use of oral steroids.

  • Success of the therapeutic regimen [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Defined as:

    • Exacerbation AND/OR
    • Increase in dose of ICS AND/OR
    • Change in ICS drug type AND/OR
    • Change in delivery device AND/OR
    • Use of additional therapy as defined by: LABAs, oral steroids, theophylline, leukotriene receptor antagonists (LTRAs)

  • Use of anti-fungals [ Time Frame: One-year ] [ Designated as safety issue: No ]
    defined as incidences of definite oral candidiasis

  • Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP. [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    BDP-equivalent dose were calculated by multiplying the Qvar and FP doses by a factor of 2. The dose at week 52 was compared with that at week 0 in order to identify the proportion of original (week 0) ICS dose.


Enrollment: 815377
Study Start Date: January 2001
Study Completion Date: July 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IPDI HFA-BDP MDI
Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Other Name: Qvar®
IPDI FP MDI
Patients who commenced inhaled corticosteroid therapy as FP via MDI
Drug: fluticasone propionate
Initiation of FP (any dose) via MDI in steroid naive patient
IPDA FP MDI
Patients who had a step up in inhaled corticosteroid therapy as FP via MDI
Drug: Fluticasone propionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
IPDA HFA-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI
Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
Other Name: Qvar
IPDI CFC-BDP MDI
Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI
Drug: Chlorofluorocarbon beclomethasone dipropionate
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
IPDA CFC-BDP MDI
Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI
Drug: Beclomethasone dipropionate
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI

Detailed Description:

While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. 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 and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.

A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).

  Eligibility

Ages Eligible for Study:   5 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care asthma patients receiving who either initiated ICS therapy as any of extrafine HFA-BDP, CFC-BDP of FP via MDI at an index prescription date (IPD), or were on existing ICs therapy (any) and had an increase in ICS dose at IPD as any of extrafine HFA-BDP, CFC-BDP of FP via MDI

Criteria

Inclusion Criteria:

Included patients must:

  • aged 5-60 years
  • evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
  • on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
  • had definite dosing instructions
  • have at least 1 year of up-to-standard (UTS) baseline data before IPD
  • have at least 1 year of UTS outcome data after IPD.

Exclusion Criteria:

  • had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
  • had a diagnostic read code for chronic respiratory disease at any time
  • For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141439

Locations
United Kingdom
General Practice Research Database
London, United Kingdom, SW8 5NQ
Sponsors and Collaborators
Research in Real-Life Ltd
Teva Pharmaceutical Industries
Investigators
Principal Investigator: David Price, Prof. MD Company Director
Study Director: Alison Chisholm, MSc Research Project Director
  More Information

Additional Information:
Publications:

Responsible Party: Professor David Price, Research in Real Life Limited
ClinicalTrials.gov Identifier: NCT01141439     History of Changes
Other Study ID Numbers: BA4
Study First Received: June 9, 2010
Last Updated: March 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Primary care
Asthma management
Inhaled corticosteroids
Beclomethasone dipropionate
Fluticasone propionate
Metred dose inhaler
Extra-fine hydrofluoroalkane
Chlorofluorocarbon

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 28, 2014