Qvar Therapy in Smoking Asthmatics

NCT01729351 | Completed DMC

• 1 other identifier: R01911
• Study Type: observational
• Target: 7,195
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Smoking

Keywords

Primary Care; Particle size; beclomethasone dipropionate; Asthma Management; Maintenance Therapy; Metered-Dose Inhaler; Smoking

Outcome Measures

Primary Outcomes (2)

• 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: 1. Asthma related hospital attendance or admission, OR A\&E attendance, OR 2. Use of acute oral steroids.

  1 year

Secondary Outcomes (8)

• Exacerbation definition based on clinical experience

  1 year

• Asthma control proxy excluding SABA usage

  1 year

• Treatment Success

  1 year

• Definite asthma-related hospitalisations

  1 year

• ICS Compliance

  1 year

Study Arms (6)

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

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Related Publications (4)

• 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.

  PMID: 20692026 BACKGROUND

• 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.

  PMID: 21752116 BACKGROUND

• 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.

  PMID: 10212105 BACKGROUND

• 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.

  PMID: 19067497 BACKGROUND

Related Links

• Clinical Practice Research Database

MeSH Terms

Conditions

Asthma; Smoking

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Study Officials

• David Professor Price

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Price

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 20, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 20, 2012

Record last verified: 2012-11