Qvar Therapy in Smoking Asthmatics

Research in Real-Life Ltd7,195 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

7,195

Conditions

Asthma Smoking

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 .

Outcomes

Primary Outcomes

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

Time frame: 1 year

Asthma Exacerbations (ATS Definition)

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.

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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).

Data from ClinicalTrials.gov

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