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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
| |
| 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 |
| |
| IPDI HFA-BDP MDI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-fine hydrofluoroalkane beclomethasone MDI | Drug | Step-up in baseline BDP-equivalent ICS dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of exacerbations; exacerbation rate ratio; time to first after IPD | Where exacerbations are defined as:
| Two-year outcome period |
| COPD treatment success |
| Two-year outcome period |
| Measure | Description | Time Frame |
|---|---|---|
| COPD treatment success factoring in change in therapy | Defined as absence of:
| Two-year outcome period |
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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)
Exclusion Criteria:
- A diagnostic read code for any other chronic respiratory disease (except asthma)
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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
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| Name | Affiliation | Role |
|---|---|---|
| David Price, Prof. MD | Company Director | Principal Investigator |
| Alison Chisholm, MSc | Research Project Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice Research Database | London | London | SW8 5NQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15672843 | Background | Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026. | |
| 17113277 | Background | Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17. |
| Label | URL |
|---|---|
| Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation) | View source |
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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
|
| 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 |
|
| Chlorofluorocarbon beclomethasone metered dose inhaler | Drug | Step-up in baseline BDP-equivalent ICS dose |
|
| Fluticasone propionate metred dose inhaler | Drug | Step-up in baseline BDP-equivalent ICS dose |
|
| Fluticasone propionate metred dose inhaler | Drug | Initiation of ICS therapy |
|
| Hydrofluoroalkane beclomethasone metred dose inhaler | Drug | Initiation of ICS therapy |
|
|
| Chlorofluorocarbon beclomethasone dipropionate | Drug | Initiation of ICS therapy |
|
| COPD treatment success factoring in change in therapy unrelated to cost savings |
Defined as absence of:
|
| Two-year outcome period |
| Change in ICS dosing | Proportion of patients who:
| Two-year outcome period |
| Rate of hospitalisations | Where hospitalisations are defined as
| Two-year outcomes |
| SABA usage | Average SABA daily dose, categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg. | Two-year outcome |
| Mortality |
| Two-years |
| Incidence of pneumonia |
| Two-year outcome |
| Incremental cost effectiveness ratio | Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations) | Two-year outcome |
| Cost of total healthcare treatment | Costs for each intervention:
| Two-year outcome |
| Costs for COPD treatment | Costs of COPD treatment:
| Two-year outcome |
| 16275363 | Background | Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034. |
| 9877489 | Background | Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346. |
| 9794854 | Background | Barber JA, Thompson SG. Analysis and interpretation of cost data in randomised controlled trials: review of published studies. BMJ. 1998 Oct 31;317(7167):1195-200. doi: 10.1136/bmj.317.7167.1195. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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