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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
The aim of this study is to compare the clinical effectiveness and cost-effectiveness of the Easyhaler® (EH) device and other DPI devices commonly used in the UK in a UK primary care asthma population of patients aged 6 to 80 years.
A recent observational study by Price et al carried out using the UK's General Practice Research Database (CPRD) to compare asthma-related outcomes for different inhaled corticosteroid (ICS) inhaler devices, using Easyhaler and dry powder inhalers (DPIs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initiation cohort | Receive their first prescription for ICS therapy as one of the study drugs |
| |
| Step-up cohort | Receive a prescription for one of the study drugs at a dose ≥50% that of their prescribed ICS dose during baseline. |
| |
| Switch cohort | switch from BUD DPI (other) to BUD EH or continue on BUD DPI (other) with no change in ICS dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide Easyhaler | Device |
| ||
| Budesonide dry powder inhaler |
| Measure | Description | Time Frame |
|---|---|---|
| asthma control (excluding SABA usage) | The Composite proxy for asthma control (excluding SABA usage) during the one-year outcome period, which is defined as: Controlled: the absence of the following during the one-year outcome period: (i) Asthma-related :
(ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids ; Uncontrolled: all others. | 1 year |
| exacerbations (ATS definition) | Total number of asthma exacerbations (ATS Definition) defined as an occurrence of: (i) Asthma-related:
(ii) Use of acute oral steroids. | 1 year |
| exacerbations (Clinical definition) | Total number of asthma exacerbations (Clinical Definition) defined as an occurrence of: (i) Asthma-related:
(ii) GP consultations for lower respiratory related tract infections (iii) Use of acute oral steroids. | 1 year |
| asthma control (including SABA usage) | The Composite proxy for asthma control (including SABA usage) during the one-year outcome period, which is defined as: Controlled: the absence of the following during the one-year outcome period: (iv) Asthma-related :
(v) GP consultations for lower respiratory tract infection (vi) Prescriptions for acute courses of oral steroids ; Plus: (vii) Average prescribed daily dose ≤200mg of Salbutamol / ≤500mg of terbutaline. Uncontrolled: all others. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| treatment success definition 1 | Treatment Success (Definition 1) defined as: Successful: the absence of the following during the one-year outcome period (i) Asthma-related:
(ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids (iv) Any additional or change in therapy:
Unsuccessful: all others. |
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Inclusion Criteria:
Patients must also meet the following inclusion criteria:
(1) Aged: 6-80 years - stratified 6-11 years; 12-60 years; ≥61 years to allow paediatrics and adolescent / adult sub analyses; and to allow for the exclusion of elderly (aged 61+) smokers and ex-smokers if required.
(2) On-going asthma therapy: ≥2 prescriptions for asthma during the outcome period (i.e. ≥1 prescription (for any asthma therapy) in addition to the prescription for ICS at IPD (initiation / step-up/ switch).
(3) Evidence of active asthma:
(4) Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD).
Exclusion Criteria:
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This will be a retrospective, observational study consisting of a one-year baseline period immediately prior to an index prescription date (IPD), and a one-year outcome period immediately following the index date.
At the IPD, patients either:
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| Name | Affiliation | Role |
|---|---|---|
| David Price | Research in real life | 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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| Device |
|
| 1 year |
| SABA dosages | (average daily dose during outcome year) | 1 year |
| adherence to ICS therapy | categorised as: <50%, 50-<70%, 70-<100%, ≥100%. | 1 year |
| Medication Possession Ratio (MPR) | The Medication Possession Ratio (MPR) for ICS is defined using the following formula. Medication Possession Ratio = (no. of days supply of ICS/365)x 100% The numerator is truncated at 365 if greater than 365. The MPR is a measure of adherence to therapy and a cut-off of 80% has previously been used in categorising asthma patients as adherent or non-adherent; the MPR has therefore been categorised as a dichotomous variable: < 80% and ≥ 80% for this analysis. | 1 year |
| Treatment success (definition 2) | Treatment Success (Definition 2) defined as: Successful: the absence of the following during the one-year outcome period (i) Asthma-related:
Unsuccessful: all others. | 1 year |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |