Qvar Therapy in Smoking Asthmatics

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729351
• Other study ID #: R01911
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: November 14, 2012
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2012
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7195
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Smoking

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Teva Pharmaceutical Industries

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Definite asthma-related hospitalisations	Hospitalisations coded with an asthma read code	1 year	No
Secondary	ICS Compliance	Based on prescription refills	1 year	No
Secondary	Incidence of oral thrust	Identified as: Topical oral anti-fungal prescriptions, and / or; Coded for oral candidiasis	1 year	No
Secondary	SABA Dose	Average daily dose of short-acting beta-agonist over the outcome year	1 year	No
Secondary	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	No