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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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The purpose of this study is 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostair switch cohort | Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair |
| |
| Seretide continuation cohort | Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed dose combination salmeterol / fluticasone | Drug | Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation rate | Where an exacerbation is defined as: (i) Asthma-related
(ii) Use of oral steroids. | One-year outcome period |
| Measure | Description | Time Frame |
|---|---|---|
| Exacerbation control (a composite proxy measure) | Controlled: Absence of: (i) Asthma-related:
(ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids | One-year outcome period |
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Inclusion Criteria:
Aged:
Evidence of asthma:
Baseline FP/SAL therapy:
Exclusion Criteria:
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Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review* and either:
(i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose;
OR,
(ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimum Patient Care | Cawston | Norfolk | NR10 4FE | United Kingdom |
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| Label | URL |
|---|---|
| Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation) | View source |
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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 |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Fixed-dose combination beclometasone dipropionate / formoterol | Drug | Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy |
|
|
| Treatment success 1 | (i) Exacerbation control AND (ii) No change in therapeutic regimen:
| One-year outcome period |
| Asthma hospitalisations |
| One-year outcome period |
| Compliance with ICS/LABA therapy | Compliance calculation based on prescription refills and (where possible) compliance questionnaire data | One-year outcome period |
| Use of reliever medication | average daily dosage during outcome year. Outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms. | One-year outcome period |
| Cost of therapeutic regimen. | Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year | One-year outcome period |
| Asthma-related / respiratory hospitalisations |
| one year outcome period |
| Oral Thrush | Identified as: (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis | One-year outcome period |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |