Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Hydrofluoroalkane beclomethasone metred dose inhalerDrug: Extra-fine hydrofluoroalkane beclomethasone MDIDrug: Chlorofluorocarbon beclomethasone dipropionateDrug: Chlorofluorocarbon beclomethasone metered dose inhaler
- Registration Number
- NCT01141452
- Lead Sponsor
- Research in Real-Life Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815377
-
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)
-
- A diagnostic read code for any other chronic respiratory disease (except asthma)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IPDI FP MDI Fluticasone propionate metred dose inhaler 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 IPDI HFA-BDP MDI Hydrofluoroalkane beclomethasone metred dose inhaler 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 IPDA FP MDI Fluticasone propionate metred dose inhaler 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 IPDA HFA-BDP MDI Extra-fine hydrofluoroalkane beclomethasone 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 IPDI CFC-BDP MDI Chlorofluorocarbon beclomethasone dipropionate 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 IPDA CFC-BDP MDI Chlorofluorocarbon beclomethasone metered dose inhaler 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
- Primary Outcome Measures
Name Time Method Total number of exacerbations; exacerbation rate ratio; time to first after IPD 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 windowCOPD treatment success 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 Outcome Measures
Name Time Method COPD treatment success factoring in change in therapy Two-year outcome period Defined as absence of:
* Exacerbations; and/or
* Increase in dose of inhaled steroid; and/or
* Change in delivery device, and/or
* Change in ICS
* Use of additional therapy not received in baseline year, split by:
* LABA
* Theophylline
* LTRAs.SABA usage Two-year outcome Average SABA daily dose, categorised as: 0mcg, \>0-100mcg, \>100-200mcg, \>200-400mcg, \>400-800mcg, \>800mcg.
Mortality Two-years * Respiratory mortality
* All-cause mortalityIncremental cost effectiveness ratio Two-year outcome Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)
COPD treatment success factoring in change in therapy unrelated to cost savings Two-year outcome period Defined as absence of:
* Exacerbations; and/or
* Increase in dose of inhaled steroid; and/or
* Use of additional therapy not received in baseline year, split by:
* LABA
* Theophylline
* LTRAs.Rate of hospitalisations Two-year outcomes Where hospitalisations are defined as
* Admissions and A\&E coded as:
* lower respiratory-related, or
* for COPD
* Admissions and A\&E coded as:
* lower respiratory-related, or
* for COPD
* admission attendance occurring within a ±7 day window of an LRTI treated with antibiotics.Incidence of pneumonia Two-year outcome * Unconfirmed (i.e. all unique patients with codes for pneumonia) AND
* Confirmed:
* chest X-ray within a month of a pneumonia diagnosis, or
* hospitalisation within a month of a pneumonia diagnosisChange in ICS dosing Two-year outcome period Proportion of patients who:
* Remained on the same ICS (and/or combination therapy) throughout the outcome period
* Remained on the same ICS dose throughout the outcome period, but had another therapy added
* Received an ICS dose increase and / or therapy added to their ICS during the outcome period.Costs for COPD treatment Two-year outcome Costs of COPD treatment:
* including ICS costs
* excluding ICS costsCost of total healthcare treatment Two-year outcome Costs for each intervention:
* including ICS costs
* excluding ICS costs
Trial Locations
- Locations (1)
General Practice Research Database
🇬🇧London, United Kingdom