Qvar vs FP in Pediatrics

June 13, 2013 updated by: Research in Real-Life Ltd

Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
  2. 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.

Study Type

Observational

Enrollment (Actual)

2654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthma patients who initiate ICS therapy as one of:

HFA-BDP pMDI FP pMDI

Description

Inclusion Criteria:

  1. Aged: 5-11 years
  2. Evidence of asthma (diagnostic code and/or current asthma therapy);
  3. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IPDI Qvar
ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate
Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate
Other Names:
  • Qvar®
IPDI FP
ICS initiation as fluticasone propionate
Drug: Fluticasone propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proxy risk domain asthma control
Time Frame: One year outcome period

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

  1. Asthma-related:

    • Hospital attendance or admission, OR
    • A&E attendance, OR
    • Out of hours attendance, OR
    • Out-patient department attendance
  2. GP consultations for lower respiratory tract infection
  3. Prescriptions for acute courses of oral steroids .
One year outcome period
Asthma exacerbation rate ratio
Time Frame: One year outcome period

Where exacerbations are defined as an occurrence of:

Defined as an occurrence of:

  1. Asthma related:

    • Hospital admission, OR
    • A&E attendance, OR
  2. Use of acute oral steroids.
One year outcome period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year outcome period
Hospitalisation rates
Time Frame: One year outcome period

Asthma-related hospitalisations

  1. Definite: Hospitalisations coded with an asthma read code
  2. 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

  1. Definite: Hospitalisations coded with a lower respiratory code
  2. 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
One year outcome period
Treatment success
Time Frame: One year outcome period
Asthma control and no change in therapy
One year outcome period
Adherence to ICS therapy
Time Frame: One year outcome period
Categorised as: <50%, 50-<70%, 70-<100%, ≥100%.
One year outcome period
Use of short-acting beta2-agonist ("reliever") therapy
Time Frame: One year outcome period
One year outcome period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research in Real-Life Ltd

Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: David Price, Research in Real Life

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

June 14, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R02511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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