Real-Life evaluation of asthma control and exacerbation risk in patients treated with fluticasone propionate / formotérol fixed-dose association (RealLiffe - FLT9507)

Study identification

• EU PAS number:
  EUPAS14418
• Study ID:
  14419
• Official title and acronym:
  Real-Life evaluation of asthma control and exacerbation risk in patients treated with fluticasone propionate / formotérol fixed-dose association (RealLiffe - FLT9507)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This is an open label, multi-centre non interventional study in approximately 1225 patients with asthma in 175 centres in France. The main objective of the study is to describe the proportion of patients with “well controlled” asthma according to the Asthma Control Questionnaire (ACQ) criteria after 6 months of treatment with Flutiform® 125µg/10µg or 50µg/5µg. The study consists of 2 visits: one at Baseline when Flutiform® is initiated and the second after 6 months of treatment. Eligible patients are to be treated and followed according to usual physician practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Mundipharma

Study timelines

Date when funding contract was signed

Planned:28/09/2015

Actual:28/09/2015

Study start date

Planned:28/09/2015

Actual:28/09/2015

Data analysis start date

Planned:01/12/2016

Date of final study report

Planned:01/02/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Mundipharma SAS

Regulatory

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