Chronic Obstructive Pulmonary Disease
Conditions
Keywords
chronic obstructive pulmonary disease, inhaled corticosteroid, increase, initiate, exacerbations, treatment success
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.
Interventions
Initiation of ICS therapy
DRUGFluticasone propionate metred dose inhaler
Step-up in baseline BDP-equivalent ICS dose
DRUGHydrofluoroalkane beclomethasone metred dose inhaler
Initiation of ICS therapy
DRUGExtra-fine hydrofluoroalkane beclomethasone MDI
Step-up in baseline BDP-equivalent ICS dose
DRUGChlorofluorocarbon beclomethasone metered dose inhaler
Step-up in baseline BDP-equivalent ICS dose
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Research in Real-Life Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 window |
| COPD 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
| Measure | Time frame | Description |
|---|---|---|
| Change 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. |
| 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. |
| 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 mortality |
| 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. |
| Incremental cost effectiveness ratio | Two-year outcome | Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations) |
| Cost of total healthcare treatment | Two-year outcome | Costs for each intervention: * including ICS costs * excluding ICS costs |
| Costs for COPD treatment | Two-year outcome | Costs of COPD treatment: * including ICS costs * excluding ICS costs |
| 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 diagnosis |
| 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. |
Countries
United Kingdom
Outcome results
None listed