Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstructive Pulmonary Disease (COPD) in a Representative UK Primary Care Patient Population
Overview
- Phase
- Not Applicable
- Intervention
- Fluticasone propionate metred dose inhaler
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Research in Real-Life Ltd
- Enrollment
- 815377
- Locations
- 1
- Primary Endpoint
- Total number of exacerbations; exacerbation rate ratio; time to first after IPD
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.
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, patients recruited to asthma RCTs are estimated to represent less than 10% of the 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. Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP. Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios: 1. before a diagnosis of COPD is made 2. unlicensed use as monotherapy, or in combination with long-acting bronchodilators The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged ≥40 years at index prescription date
- •COPD diagnosis:
- •diagnostic code, and
- •≥2 prescriptions for COPD therapy in baseline year (at different points in time)
- •For the ICS increase cohort (i.e. IPDA) ≥1 of these prescriptions must be for ICS therapy.
- •Commence ICS therapy at any time (even if before COPD diagnosis is made)
Exclusion Criteria
- •A diagnostic read code for any other chronic respiratory disease (except asthma)
Arms & Interventions
IPDA FP MDI
Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as fluticasone via metered dose inhaler
Intervention: Fluticasone propionate metred dose inhaler
IPDA HFA-BDP MDI
Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
Intervention: Extra-fine hydrofluoroalkane beclomethasone MDI
IPDA CFC-BDP MDI
Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler
Intervention: Chlorofluorocarbon beclomethasone metered dose inhaler
IPDI CFC-BDP MDI
Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler
Intervention: Chlorofluorocarbon beclomethasone dipropionate
IPDI HFA-BDP MDI
Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
Intervention: Hydrofluoroalkane beclomethasone metred dose inhaler
IPDI FP MDI
Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as fluticasone propionate via metered dose inhaler
Intervention: Fluticasone propionate metred dose inhaler
Outcomes
Primary Outcomes
Total number of exacerbations; exacerbation rate ratio; time to first after IPD
Time Frame: Two-year outcome period
Where exacerbations are defined as: * Unscheduled hospital admissions / A\&E attendances:\* * For COPD (definite code) and * Lower respiratory tract infections (LRTI) treated with antibiotics * Acute use of oral steroids * Antibiotics use with a lower respiratory read code within a ±5-day window
COPD treatment success
Time Frame: Two-year outcome period
* No recorded hospital attendance for COPD or respiratory related events (i.e. with a lower respiratory read code), including: * Admission * A\&E attendance * Out of hours attendance * No exacerbations of COPD ("definite" plus "possible" prescriptions as defined above) * No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Secondary Outcomes
- COPD treatment success factoring in change in therapy(Two-year outcome period)
- SABA usage(Two-year outcome)
- Mortality(Two-years)
- Incremental cost effectiveness ratio(Two-year outcome)
- COPD treatment success factoring in change in therapy unrelated to cost savings(Two-year outcome period)
- Rate of hospitalisations(Two-year outcomes)
- Incidence of pneumonia(Two-year outcome)
- Change in ICS dosing(Two-year outcome period)
- Costs for COPD treatment(Two-year outcome)
- Cost of total healthcare treatment(Two-year outcome)