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
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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 .
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
IPDI EF HFA-BDP
Pazienti che iniziano la terapia con corticosteroidi per via inalatoria come HFA-BDP MDI extra-fine alla data indice
|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Asthma Control proxy incorporating SABA use
Lasso di tempo: 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)
Lasso di tempo: 1 year
|
Defined as an absence of the the following:
|
1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exacerbation definition based on clinical experience
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 year
|
Hospitalisations coded with an asthma read code
|
1 year
|
|
ICS Compliance
Lasso di tempo: 1 year
|
Based on prescription refills
|
1 year
|
|
Incidence of oral thrust
Lasso di tempo: 1 year
|
Identified as:
|
1 year
|
|
SABA Dose
Lasso di tempo: 1 year
|
Average daily dose of short-acting beta-agonist over the outcome year
|
1 year
|
|
Definite and probable asthma-related hospitalisations
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: David Professor Price, University of Aberdeen
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01911
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .