Qvar Therapy in Smoking Asthmatics

NCT ID: NCT01729351

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

7195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Smoking

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPDI EF HFA-BDP

Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date

No interventions assigned to this group

IPDI FP

Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date

No interventions assigned to this group

IPDI NEF HFA-BDP

Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date

No interventions assigned to this group

IPDA EF HFA-BDP

Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date

No interventions assigned to this group

IPDA FP

Patients increasing inhaled corticosteroid therapy as FP MDI at the index date

No interventions assigned to this group

IPDA NEF HFA-BDP

Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role collaborator

Research in Real-Life Ltd

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Price

Professor David Price

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Professor Price

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20692026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21752116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10212105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19067497 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.cprd.com

Clinical Practice Research Database

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01911

Identifier Type: -

Identifier Source: org_study_id