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
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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 .
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
IPDI EF HFA-BDP
Patienter, der påbegynder inhaleret kortikosteroidbehandling som ekstra fin HFA-BDP MDI på indeksdatoen
|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Control proxy incorporating SABA use
Tidsramme: 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 |
1 year
|
|
Asthma Exacerbations (ATS Definition)
Tidsramme: 1 year
|
Defined as an absence of the the following:
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exacerbation definition based on clinical experience
Tidsramme: 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 |
1 year
|
|
Asthma control proxy excluding SABA usage
Tidsramme: 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 |
1 year
|
|
Treatment Success
Tidsramme: 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). |
1 year
|
|
Definite asthma-related hospitalisations
Tidsramme: 1 year
|
Hospitalisations coded with an asthma read code
|
1 year
|
|
ICS Compliance
Tidsramme: 1 year
|
Based on prescription refills
|
1 year
|
|
Incidence of oral thrust
Tidsramme: 1 year
|
Identified as:
|
1 year
|
|
SABA Dose
Tidsramme: 1 year
|
Average daily dose of short-acting beta-agonist over the outcome year
|
1 year
|
|
Definite and probable asthma-related hospitalisations
Tidsramme: 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
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David Professor Price, University of Aberdeen
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01911
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