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OpenTrials
Completed

NCT Number: NCT01877954

Qvar vs FP in Pediatrics

The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

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Key information

Conditions

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

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Observational

About this study

Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:

  • Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
  • Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged: 5-11 years
  • Evidence of asthma (diagnostic code and/or current asthma therapy);
  • Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).

Exclusion criteria

  • Had any chronic respiratory disease, except asthma, at any time; and/or
  • Patients on maintenance oral steroids during baseline year

Treatment and study plan

Extra-fine hydrofluoroalkane beclometasone dipropionate

Drug

Other names: Qvar®

Fluticasone propionate

Drug

Primary outcomes

  1. Proxy risk domain asthma control

    Time frame: One year outcome period

    Defined as the absence of the following during the one-year outcome period:

    • Asthma-related:
    • Hospital attendance or admission, OR
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance
    • GP consultations for lower respiratory tract infection
    • Prescriptions for acute courses of oral steroids .

  2. Asthma exacerbation rate ratio

    Time frame: One year outcome period

    Where exacerbations are defined as an occurrence of:

    Defined as an occurrence of:

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

Secondary outcomes

  1. Overall asthma control

    Time frame: One year outcome period

    Risk domain asthma control as defined above, plus

    (a)Average prescribed daily dose of albuterol or terbutaline of ≤200mg

  2. Hospitalisation rates

    Time frame: One year outcome period

    Asthma-related hospitalisations

    • Definite: Hospitalisations coded with an asthma read code
    • Definite and probable: Hospitalisations with an asthma read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code

    Respiratory hospitalisations

    • Definite: Hospitalisations coded with a lower respiratory code
    • Definite and probable: Hospitalisations with a lower respiratory read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code

  3. Treatment success

    Time frame: One year outcome period

    Asthma control and no change in therapy

  4. Adherence to ICS therapy

    Time frame: One year outcome period

    Categorised as: <50%, 50-<70%, 70-<100%, ≥100%.

  5. Use of short-acting beta2-agonist ("reliever") therapy

    Time frame: One year outcome period

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 in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2013
Registry last updated
Jun 14, 2013

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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