Exploratory study identifying the benefits of pMDI versus Diskus for delivering fluticasone/salmeterol combination therapy in patients with chronic obstructive pulmonary disease (COPD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8830
• EU PAS number:
  EUPAS7072
• Study ID:
  8830
• Official title and acronym:
  Exploratory study identifying the benefits of pMDI versus Diskus for delivering fluticasone/salmeterol combination therapy in patients with chronic obstructive pulmonary disease (COPD)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The aims of this exploratory study are to characterise patients with chronic obstructive pulmonary disease (COPD) initiating with fluticasone/salmeterol combination therapy delivered via pressurised metered dose inhaler (pMDI, also known as Evohaler) or Diskus (also known as Accuhaler), and to identify and compare the potential benefits of using either device in the delivery of fluticasone/salmeterol combination therapy in terms of both efficacy and adverse events, in particular:a. Number of COPD exacerbationsb. Development of pneumonia infections c. Type II diabetes diagnosisd. Therapeutic index e. Number of severe COPD-related events, including: i. Lower respiratory tract infectionsii. Oral thrush
• Study status:
  Ongoing

Research institution and networks

Institutions

Research in Real Life

Study timelines

Date when funding contract was signed

Actual: 12/12/2013

Study start date

Actual: 14/03/2014

Data analysis start date

Actual: 13/05/2014

Date of final study report

Planned: 01/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mundipharma

Study protocol

Initial protocol

R01913_Protocol_Seretide Diskus vs MDI COPD study_Mundipharma_091014_v3

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable