Qvar Therapy in Smoking Asthmatics
- Conditions
- AsthmaSmoking
- Registration Number
- NCT01729351
- Lead Sponsor
- Research in Real-Life Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7195
- 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)
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 .
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma Control proxy incorporating SABA use 1 year 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 ≤200mgAsthma Exacerbations (ATS Definition) 1 year Defined as an absence of the the following:
1. Asthma related hospital attendance or admission, OR A\&E attendance, OR
2. Use of acute oral steroids.
- Secondary Outcome Measures
Name Time Method Exacerbation definition based on clinical experience 1 year 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 steroidsAsthma control proxy excluding SABA usage 1 year 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 steroidsTreatment Success 1 year 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).Definite asthma-related hospitalisations 1 year Hospitalisations coded with an asthma read code
ICS Compliance 1 year Based on prescription refills
Incidence of oral thrust 1 year Identified as:
1. Topical oral anti-fungal prescriptions, and / or
2. Coded for oral candidiasisSABA Dose 1 year Average daily dose of short-acting beta-agonist over the outcome year
Definite and probable asthma-related hospitalisations 1 year 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