Characterising patients at risk of failed Diskus use in primary care

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8020
• EU PAS number:
  EUPAS8019
• Study ID:
  8020
• Official title and acronym:
  Characterising patients at risk of failed Diskus use in primary care
• DARWIN EU® study:
  No
• Study countries:
  Australia

  France

  Italy

  Netherlands

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  The aim of this study is to identify patient characteristics in a large sample of primary care patients that use a Diskus inhaler. The prevalence and factors associated with inhaler misuse will be investigated. In addition we aim to assess the relationship between inhalation technique and clinical outcomes. These results should assist physicians in evaluating the potential impact of the type of device prescribed to a patient.This study will answer the following questions:• Which serious errors in Diskus inhaler technique are most frequently made?• Are certain patient characteristics linked to incorrect inhaler technique for Diskus?• Are patient reported outcomes linked to incorrect inhaler technique for Diskus?• Does incorrect inhaler technique correlate to asthma risk assessment?In addition, the type and frequency of serious errors being performed when using Diskus will be analysed to better characterise patient errors and identify ways in which inhaler technique may be improved.
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Study timelines

Date when funding contract was signed

Planned: 03/09/2013

Actual: 03/09/2013

Study start date

Planned: 01/06/2011

Actual: 01/06/2011

Data analysis start date

Planned: 10/10/2013

Actual: 14/10/2013

Date of interim report, if expected

Planned: 10/01/2014

Actual: 10/01/2014

Date of final study report

Planned: 19/03/2014

Actual: 24/11/2014

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Teva, RiRL

Study protocol

Initial protocol

R01613 Characterising patients with serious errors using Diskus_ protocol for Encepp registration_241114

Regulatory

• Was the study required by a regulatory body?:
  No