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| Name | Class |
|---|---|
| Teva Branded Pharmaceutical Products R&D, Inc. | INDUSTRY |
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To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPDI EF HFA-BDP | Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date | ||
| IPDI FP | Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date | ||
| IPDI NEF HFA-BDP | Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date | ||
| IPDA EF HFA-BDP | Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date | ||
| IPDA FP | Patients increasing inhaled corticosteroid therapy as FP MDI at the index date | ||
| IPDA NEF HFA-BDP | Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date |
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| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control proxy incorporating SABA use | Where control is defined as absence of: (i)Respiratory-related: Hospital attendance or admission A&E attendance, OR Out of hours attendance, OR Out-patient department attendance (ii)GP consultations for lower respiratory tract infection (iii)Prescriptions for acute courses of oral steroids (iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg | 1 year |
| Asthma Exacerbations (ATS Definition) | Defined as an absence of the the following:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation definition based on clinical experience | Defined as: (i)Respiratory-related: Hospital attendance / admissions OR A&E attendance OR Out of hours consultation OR GP consultation OR (ii) Use of acute oral steroids | 1 year |
| Asthma control proxy excluding SABA usage |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from the analysis if they have:
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Patients are all current smokers ages between 16-70 years with evidence of asthma
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| Name | Affiliation | Role |
|---|---|---|
| David Professor Price | University of Aberdeen | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20692026 | Background | Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9. | |
| 21752116 |
| Label | URL |
|---|---|
| Clinical Practice Research Database | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Control defined as absence of: (i) Respiratory-related: Hospital attendance or admission A&E attendance, OR Out of hours attendance, OR Out-patient department attendance (ii)GP consultations for lower respiratory tract infection (iii)Prescriptions for acute courses of oral steroids |
| 1 year |
| Treatment Success | Success defined as: No respiratory-related: Hospital attendance or admission A&E attendance, OR Out of hours consultation, OR Out-patient department attendance No GP consultations for lower respiratory tract infection No prescriptions for acute courses of oral steroids No additional or change in therapy: Increased dose of ICS (≥50% increase), and/or Change in ICS and/or Change in delivery device, and/or Use of additional therapy as defined by: LABA, theophylline, leukotriene receptor antagonists (LTRAs). | 1 year |
| Definite asthma-related hospitalisations | Hospitalisations coded with an asthma read code | 1 year |
| ICS Compliance | Based on prescription refills | 1 year |
| Incidence of oral thrust | Identified as:
| 1 year |
| SABA Dose | Average daily dose of short-acting beta-agonist over the outcome year | 1 year |
| Definite and probable asthma-related hospitalisations | Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code | 1 year |
| Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14. |
| 10212105 | Background | Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413. |
| 19067497 | Background | Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |