Clinical trial NCT01729351: Qvar Therapy in Smoking Asthmatics
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Smoking
Keywords: Primary Care
Particle size
beclomethasone dipropionate
Asthma Management
Maintenance Therapy
Metered-Dose Inhaler
Smoking
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2012-11-20
Enrollment: 7195
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are all current smokers ages between 16-70 years with evidence of asthma

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Asthma Control proxy incorporating SABA use
timeFrame: 1 year
measure: Asthma Exacerbations (ATS Definition)
timeFrame: 1 year
Secondary outcomes:
measure: Exacerbation definition based on clinical experience
timeFrame: 1 year
measure: Asthma control proxy excluding SABA usage
timeFrame: 1 year
measure: Treatment Success
timeFrame: 1 year
measure: Definite asthma-related hospitalisations
timeFrame: 1 year
measure: ICS Compliance
timeFrame: 1 year
measure: Incidence of oral thrust
timeFrame: 1 year
measure: SABA Dose
timeFrame: 1 year
measure: Definite and probable asthma-related hospitalisations
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Aberdeen
name: David Professor Price
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. doi: 10.1136/thx.54.5.413.
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.