Qvar Therapy in Smoking Asthmatics

Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01729351

Enrollment

7195

Registered

2012-11-20

Start date

2011-11-30

Completion date

2012-06-30

Last updated

2012-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Smoking

Keywords

Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler, Smoking

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

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 .

Design outcomes

Primary

Measure	Time frame	Description
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 ≤200mg
Asthma 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

Measure	Time frame	Description
Treatment 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
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 steroids
SABA 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
Incidence of oral thrust	1 year	Identified as: 1. Topical oral anti-fungal prescriptions, and / or 2. Coded for oral candidiasis
Asthma 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 steroids

Outcome results