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OpenTrials
Completed

NCT Number: NCT01729351

Qvar Therapy in Smoking Asthmatics

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.

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Key information

Conditions

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

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Primary outcomes

  1. Asthma Control proxy incorporating SABA use

    Time frame: 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

  2. Asthma Exacerbations (ATS Definition)

    Time frame: 1 year

    Defined as an absence of the the following:

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

Secondary outcomes

  1. Exacerbation definition based on clinical experience

    Time frame: 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

  2. Asthma control proxy excluding SABA usage

    Time frame: 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

  3. Treatment Success

    Time frame: 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).

  4. Definite asthma-related hospitalisations

    Time frame: 1 year

    Hospitalisations coded with an asthma read code

  5. ICS Compliance

    Time frame: 1 year

    Based on prescription refills

  6. Incidence of oral thrust

    Time frame: 1 year

    Identified as:

    • Topical oral anti-fungal prescriptions, and / or
    • Coded for oral candidiasis

  7. SABA Dose

    Time frame: 1 year

    Average daily dose of short-acting beta-agonist over the outcome year

  8. Definite and probable asthma-related hospitalisations

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2012
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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