Qvar vs FP in Pediatrics
- Conditions
- Asthma
- Interventions
- Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate
- Registration Number
- NCT01877954
- Lead Sponsor
- Research in Real-Life Ltd
- Brief Summary
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
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:
1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2654
- 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).
- Had any chronic respiratory disease, except asthma, at any time; and/or
- Patients on maintenance oral steroids during baseline year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IPDI FP Fluticasone propionate ICS initiation as fluticasone propionate IPDI Qvar Extra-fine hydrofluoroalkane beclometasone dipropionate ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate
- Primary Outcome Measures
Name Time Method Proxy risk domain asthma control One year outcome period Defined as the absence of the following during the one-year outcome period:
1. Asthma-related:
* Hospital attendance or admission, OR
* A\&E attendance, OR
* Out of hours attendance, OR
* Out-patient department attendance
2. GP consultations for lower respiratory tract infection
3. Prescriptions for acute courses of oral steroids .Asthma exacerbation rate ratio One year outcome period Where exacerbations are defined as an occurrence of:
Defined as an occurrence of:
1. Asthma related:
* Hospital admission, OR
* A\&E attendance, OR
2. Use of acute oral steroids.
- Secondary Outcome Measures
Name Time Method Overall asthma control One year outcome period Risk domain asthma control as defined above, plus
(a)Average prescribed daily dose of albuterol or terbutaline of ≤200mgHospitalisation rates One year outcome period Asthma-related hospitalisations
1. Definite: Hospitalisations coded with an asthma read code
2. 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
1. Definite: Hospitalisations coded with a lower respiratory code
2. 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 codeTreatment success One year outcome period Asthma control and no change in therapy
Adherence to ICS therapy One year outcome period Categorised as: \<50%, 50-\<70%, 70-\<100%, ≥100%.
Use of short-acting beta2-agonist ("reliever") therapy One year outcome period