Asthma
Conditions
Keywords
hydrofluoroalkane beclomethasone, fluticasone, paediatrics, real-life, observational, primary care
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.
Interventions
DRUGFluticasone propionate
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Research in Real-Life Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
1. Aged: 5-11 years 2. Evidence of asthma (diagnostic code and/or current asthma therapy); 3. 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
1. Had any chronic respiratory disease, except asthma, at any time; and/or 2. Patients on maintenance oral steroids during baseline year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | One year outcome period | Asthma control and no change in therapy |
| 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 ≤200mg |
| Use of short-acting beta2-agonist (reliever) therapy | One year outcome period | — |
| Adherence to ICS therapy | One year outcome period | Categorised as: \<50%, 50-\<70%, 70-\<100%, ≥100%. |
| Hospitalisation 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 code |
Outcome results
None listed