An observational study in Chronic Obstructive Pulmonary Disease, sponsored by Research in Real-Life Ltd. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-03-08.
Sponsored by Research in Real-Life Ltd · Observational
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.
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:
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.
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This study's enrollment of 815,377 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
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Primary care COPD patients who at an index prescription date either initiated ICS therapy as extrafine HFA-BDP, CFC-BDP or FP via MDI or had an increase in baseline BDP-equivalent ICS dose the index data as extrafine HFA-BDP, CFC-BDP or FP via MDI
COPD diagnosis:
≥2 prescriptions for COPD therapy in baseline year (at different points in time)
Exclusion Criteria:
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
Drug: 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 extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
Drug: 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 chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler
Drug: Chlorofluorocarbon beclomethasone metered 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 chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler
Drug: 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 hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
Drug: 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 fluticasone propionate via metered dose inhaler
Drug: Fluticasone propionate metred dose inhaler
Step-up in baseline BDP-equivalent ICS dose
Also known as: Qvar®
Step-up in baseline BDP-equivalent ICS dose
Step-up in baseline BDP-equivalent ICS dose
Initiation of ICS therapy
Initiation of ICS therapy
Also known as: Qvar®
Initiation of ICS therapy
Total number of exacerbations; exacerbation rate ratio; time to first after IPD
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
Time frame: Two-year outcome period
COPD treatment success
* 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.
Time frame: Two-year outcome period
COPD treatment success factoring in change in therapy
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.
Time frame: Two-year outcome period
COPD treatment success factoring in change in therapy unrelated to cost savings
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.
Time frame: Two-year outcome period
Change in ICS dosing
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.
Time frame: Two-year outcome period
Rate of hospitalisations
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.
Time frame: Two-year outcomes
SABA usage
Average SABA daily dose, categorised as: 0mcg, \>0-100mcg, \>100-200mcg, \>200-400mcg, \>400-800mcg, \>800mcg.
Time frame: Two-year outcome
Mortality
* Respiratory mortality * All-cause mortality
Time frame: Two-years
Incidence of pneumonia
* 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
Time frame: Two-year outcome
Incremental cost effectiveness ratio
Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)
Time frame: Two-year outcome
Cost of total healthcare treatment
Costs for each intervention: * including ICS costs * excluding ICS costs
Time frame: Two-year outcome
Costs for COPD treatment
Costs of COPD treatment: * including ICS costs * excluding ICS costs
Time frame: Two-year outcome
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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