Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy (QvarvsCombo)

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01697722
First received: September 28, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Asthma
Drug: Extra-fine hydrofluoroalkane-beclometasone dipropionate
Drug: ICS / LABA via separate pMDI and / or BAI inhalers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

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

    Defined as the absence of (i) Exacerbation:

    1. Unscheduled hospital admissions / A&E attendance for asthma, OR
    2. 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:

    1. Increased dose of ICS, and/or
    2. Change in ICS/LABA, and/or
    3. Change in delivery device, and/or
    4. Use of additional therapy as defined by: theophylline, LTRAs, oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).

  • Success of therapeutic regimen (sensitivity - independent of cost saving) [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]

    Success: defined as the absence of

    (i) Exacerbation:

    1. Unscheduled hospital admissions / A&E attendance for asthma, OR
    2. 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:

    1. Increased dose of ICS, and/or
    2. Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs), oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).

  • average SABA daily dose during outcome year [ Time Frame: One-year outcome period ] [ Designated as safety issue: No ]
    Average daily dose categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg).

  • Hospitalisations [ Time Frame: One-year outcome period ] [ Designated as safety issue: Yes ]
    Mean number of asthma and respiratory-related hospitalisations recorded per patient during the outcome year


Enrollment: 815377
Study Start Date: January 1991
Study Completion Date: February 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Step-up as FDC ICS/LABA
ICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).
Step up as separate therapies
ICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).
Drug: ICS / LABA via separate pMDI and / or BAI inhalers
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
Other Name: ICS+LABA separates
Qvar step-up
ICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate
Drug: Extra-fine hydrofluoroalkane-beclometasone dipropionate
Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI
Other Name: Qvar

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA, BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either:

(i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no increase in daily BDP-equivalent dose).

Criteria

Inclusion Criteria:

  • Aged: 4-60 years:

    • Paediatric cohort (aged 4-11 years), and
    • Adult cohort (aged 12-60 years)
    • Aged 61-80 years and never smoked for an additional elderly cohort;
  • Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma prescriptions, including one ICS prescription, at different points in time during the year prior to IPD (the baseline year)
  • Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to IPD, and at least 1 other asthma prescription during the same period
  • Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the 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 (other than asthma)
  • any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year
  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: NCT01697722

Locations
United Kingdom
General Practice Research Database
London, United Kingdom
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: David Price, Professor David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01697722     History of Changes
Other Study ID Numbers: BA21
Study First Received: September 28, 2012
Last Updated: October 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Primary care
Asthma management
Inhaled corticosteroids
Extra-fine hydrofluoroalkane
Long-acting beta-agonist
Fixed-dose combination therapy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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

ClinicalTrials.gov processed this record on October 19, 2014