Qvar vs FP in Pediatrics

Study Overview
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Brief Summary
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The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

Detailed Description
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Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted: Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Official Title
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Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population

Conditions
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Asthma

Intervention / Treatment
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* Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate
* Drug: Fluticasone propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged: 5-11 years Evidence of asthma (diagnostic code and/or current asthma therapy); Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD). Exclusion Criteria: Had any chronic respiratory disease, except asthma, at any time; and/or Patients on maintenance oral steroids during baseline year

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 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 Qvar<br>ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate | Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate<br> <br> * Other names: Qvar®;|
| IPDI FP<br>ICS initiation as fluticasone propionate | Drug: Fluticasone propionate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proxy risk domain asthma control | Defined as the absence of the following during the one-year outcome period: Asthma-related: Hospital attendance or admission, OR A&E attendance, OR Out of hours attendance, OR Out-patient department attendance GP consultations for lower respiratory tract infection Prescriptions for acute courses of oral steroids . | One year outcome period | 
| Asthma exacerbation rate ratio | Where exacerbations are defined as an occurrence of: Defined as an occurrence of: Asthma related: Hospital admission, OR A&E attendance, OR Use of acute oral steroids. | One year outcome period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall asthma control | Risk domain asthma control as defined above, plus (a)Average prescribed daily dose of albuterol or terbutaline of ≤200mg | One year outcome period | 
| Hospitalisation rates | Asthma-related hospitalisations Definite: Hospitalisations coded with an asthma read code Definite and probable: Hospitalisations with an asthma read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code Respiratory hospitalisations Definite: Hospitalisations coded with a lower respiratory code Definite and probable: Hospitalisations with a lower respiratory read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code | One year outcome period | 
| Treatment success | Asthma control and no change in therapy | One year outcome period | 
| Adherence to ICS therapy | Categorised as: <50%, 50-<70%, 70-<100%, ≥100%. | One year outcome period | 
| Use of short-acting beta2-agonist (reliever) therapy |  | One year outcome period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrofluoroalkane beclomethasone, fluticasone, paediatrics, real-life, observational, primary care