Real-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK primary care population - Study 1 (Real-life acceptability of Eklira)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8872
• EU PAS number:
  EUPAS6573
• Study ID:
  8872
• Official title and acronym:
  Real-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK primary care population - Study 1 (Real-life acceptability of Eklira)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  To evaluate the real-life effectiveness of the antimuscarine bronchodilator aclidinium bromide (Eklira®) in three combined studies following the launch of Eklira® in the UK. This first study involves characterising patients prescribed aclidinium bromide from tiotropium, and determining how many patients are satisfied with their change to aclidinium therapy. This will determine the acceptability of aclidinium in clinical practice.
• Study status:
  Finalised

Research institution and networks

Institutions

Research in Real Life

Study timelines

Date when funding contract was signed

Planned: 26/09/2013

Actual: 26/09/2013

Study start date

Planned: 01/10/2013

Actual: 01/10/2013

Data analysis start date

Planned: 02/06/2014

Actual: 13/05/2014

Date of final study report

Planned: 29/08/2014

Actual: 06/10/2014

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Almirall, Research in Real Life

Study protocol

Initial protocol

2014_05_19_(R03712a) Almirall Eklira study 1 protocol-v2_ENCEPP

Regulatory

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