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

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 Overview

• Status: Completed
• Conditions: Smoking; Asthma

• Study Type: Observational
• Enrollment (Actual): 7195

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are all current smokers ages between 16-70 years with evidence of asthma

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
IPDI EF HFA-BDP; Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
IPDI FP; Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date
IPDI NEF HFA-BDP; Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date
IPDA EF HFA-BDP; Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
IPDA FP; Patients increasing inhaled corticosteroid therapy as FP MDI at the index date
IPDA NEF HFA-BDP; Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Asthma Exacerbations (ATS Definition)	Defined as an absence of the the following: Asthma related hospital attendance or admission, OR A&E attendance, OR; Use of acute oral steroids.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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).	1 year
Definite asthma-related hospitalisations	Hospitalisations coded with an asthma read code	1 year
ICS Compliance	Based on prescription refills	1 year
Incidence of oral thrust	Identified as: Topical oral anti-fungal prescriptions, and / or; Coded for oral candidiasis	1 year
SABA Dose	Average daily dose of short-acting beta-agonist over the outcome year	1 year
Definite and probable asthma-related hospitalisations	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	1 year

Collaborators and Investigators

• Sponsor: Research in Real-Life Ltd
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Principal Investigator: David Professor Price, University of Aberdeen

Publications and helpful links

General Publications

• Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.
• Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.
• Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.
• Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.

Helpful Links

• Clinical Practice Research Database

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 14, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Primary Care; Smoking; Maintenance Therapy; Metered-Dose Inhaler; Particle size; beclomethasone dipropionate; Asthma Management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: R01911