A Post-marketing, Observational Safety Study of Quinsair (Levofloxacin Hemihydrate) in Patients with Cystic Fibrosis [CLI-LEVFLAA1-01]

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47438
• EU PAS number:
  EUPAS20990
• Study ID:
  47438
• Official title and acronym:
  A Post-marketing, Observational Safety Study of Quinsair (Levofloxacin Hemihydrate) in Patients with Cystic Fibrosis [CLI-LEVFLAA1-01]
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  Observational comparative cohort study using secondary data collected from patients treated with Quinsair and a comparison cohort of patients treated with other inhaled approved antibiotic therapies enrolled in the UK CF Registry in the years 2017 to 2021. The observational cohort has been extended to evaluate the safety profile of Quinsair over a three-year period (2019 to 2021) compared to other inhaled approved antibiotic therapies in CF patients who are enrolled in the German CF Registry
• Study status:
  Ongoing

Research institutions and networks

Institutions

Cystic Fibrosis Trust

United Kingdom

German Cystic Fibrosis Registry Mainz

Study timelines

Date when funding contract was signed

Planned: 23/03/2017

Actual: 23/03/2017

Study start date

Planned: 01/01/2017

Actual: 01/01/2017

Date of interim report, if expected

Planned: 28/02/2019

Actual: 31/01/2019

Date of final study report

Planned: 20/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Farmaceutici S.p.A.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)