Qvar Therapy in Smoking Asthmatics

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population

Conditions
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Asthma, Smoking

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 16-70 years Current smokers - explicitly coded in patient records or captured in patient questionnaires Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1 prescription in addition to IPD prescription) ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data) Exclusion Criteria: Patients will be excluded from the analysis if they have: Any chronic respiratory disease other than asthma Are prescribed: Maintenance oral steroid therapy during the baseline year Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD Multiple ICS prescriptions at IPD or immediately before .

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IPDI EF HFA-BDP<br>Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date | |
| IPDI FP<br>Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date | |
| IPDI NEF HFA-BDP<br>Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date | |
| IPDA EF HFA-BDP<br>Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date | |
| IPDA FP<br>Patients increasing inhaled corticosteroid therapy as FP MDI at the index date | |
| IPDA NEF HFA-BDP<br>Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Asthma related hospital attendance or admission, OR A&E attendance, OR Use of acute oral steroids. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: Topical oral anti-fungal prescriptions, and / or Coded for oral candidiasis | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler, Smoking