Effectiveness of Fostair® (ICS/LABA) vs. dual bronchodilation (LABA/LAMA) in COPD (FELICITI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31702
• EU PAS number:
  EUPAS29223
• Study ID:
  31702
• Official title and acronym:
  Effectiveness of Fostair® (ICS/LABA) vs. dual bronchodilation (LABA/LAMA) in COPD (FELICITI)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Historical cohort study comparing effectiveness of Fostair® (ICS/LABA) against dual bronchodilation in frequently exacerbating patients with chronic obstructive pulmonary disease (COPD). The primary objective is to examine whether the effectiveness, in terms of reducing COPD exacerbations, of initiating Fostair® is non-inferior, with a non-inferiority margin of 15%, to that of dual bronchodilation (LAMA/LABA) in patients with COPD. The secondary objective is to study the potential heterogeneity of the comparative effectiveness driven by severity of COPD and blood eosinophil count.
• Study status:
  Ongoing

Research institution and networks

Institutions

Observational & Pragmatic Research Institute Pte (OPRI)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 31/10/2018

Actual: 31/10/2018

Study start date

Planned: 03/04/2019

Actual: 03/04/2019

Data analysis start date

Planned: 24/04/2019

Actual: 24/04/2019

Date of interim report, if expected

Planned: 31/05/2019

Actual: 12/08/2019

Date of final study report

Planned: 31/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Pharmaceuticals

Regulatory

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