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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDP/FOR | Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose |
| |
| FP/SAL | Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP/SAL | Drug |
|
| |
| BDP/FOR |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbations : rate ratio | Where an exacerbation is defined as: (i) Asthma-related
Where:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation control | Proxy Asthma Control. The absence of exacerbation and the absence of antibiotic prescribing for lower respiratory tract infections (often a pragmatic prescribing decision taken by GPs in real world practice). Controlled: (i) No Asthma-related:
Uncontrolled: (i) All others. a. Proxy Asthma Control + SABA As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only
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| Name | Affiliation | Role |
|---|---|---|
| David Price | University of Aberdeen | Principal Investigator |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Drug |
|
|
| 1 year |
| Proxy asthma control + SABA | As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily | 1 year |
| Treatment success | No exacerbation and no change in therapy during the outcome year, where changes are: •≥50% increase in ICS dose relative to IPD dose, and/or
| 1 year |
| Asthma Control (including SABA) | Defined as proxy asthma control (above) plus: Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline | 1 year |
| Hospitalisations | Asthma-related hospitalizations
Respiratory hospitalisations
| 1 year |
| Medication possession ratio | For ICS, defined as the number of days supply of ICS / 365 x 100% Controller/reliever ratio: number of controller units/ number of controller units + number of reliever units. Controllers are defined as ICS (including fixed combination ICS/LABA) and LTRA, while relievers are SABA. For ICS a unit is taken to be one inhaler; for LTRA a unit is one prescription. | 1 year |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |