Incidence of oral thrush in COPD patients prescribed ICS as part of ICS/LABA therapy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14064
• EU PAS number:
  EUPAS12762
• Study ID:
  14064
• Official title and acronym:
  Incidence of oral thrush in COPD patients prescribed ICS as part of ICS/LABA therapy
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A historical cohort, UK database study in patients with COPD comparing the incidence of oral thrush in those prescribed ICS as part of fixed-dose combination ICS/LABA therapies, with that in patients prescribed long-acting bronchodilator therapies without ICS
• Study status:
  Finalised

Research institutions and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 26/02/2015

Actual: 05/03/2015

Study start date

Planned: 07/04/2015

Actual: 07/04/2015

Data analysis start date

Planned: 07/04/2015

Actual: 07/04/2015

Date of interim report, if expected

Planned: 12/05/2015

Actual: 12/05/2015

Date of final study report

Planned: 30/05/2016

Actual: 29/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

TEVA Pharmaceutical Industries

Study protocol

Initial protocol

150407_R00115_Oral_thrush_ICS_LABA_protocol_V1.5b

Regulatory

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