Chiesi Farmaceutici

This sponsor has funded 17 studies across 26 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3750 Ongoing Unspecified LPLD Registry, observational longitudinal pharmaco-epidemiologic study in lipoprotein lipase deficient (LPLD) patients, either treated or not treated... No No
9142 Finalised Not included in RMP Characterising patients and examining real-life outcomes for UK patients with COPD initiating on or changing to Fostair (REACH II) Yes Yes
12292 Ongoing Non-EU RMP-only A long term prospective observational study of the safety and tolerability of Bramitob® administered twice daily over three 28-day “on”/28-day “off”... No No
13185 Planned Not included in RMP Inhaled Corticosteroid and Real Life unlicensed Spacer Use (stage 1) (ICARUS 1) Yes No
13194 Ongoing Not included in RMP ICARUS: Inhaled Corticosteroid And Real life Unlicensed Spacer use – stage 2 (ICARUS 2) Yes No
19323 Ongoing Not included in RMP Effectiveness of triple therapy vs. dual bronchodilation in COPD (Effectiveness of triple therapy in COPD) Yes No
19486 Ongoing Not included in RMP Observational follow-up study to evaluate the long term efficacy of (HOLO-UP) Yes No
20990 Ongoing EU RMP category 1 A Post-marketing, Observational Safety Study of Quinsair (Levofloxacin Hemihydrate) in Patients with Cystic Fibrosis [CLI-LEVFLAA1-01] No No
26916 Finalised Not included in RMP Comparative study of COPD double therapy versus triple therapy: an EGB data analysis No No
29038 Ongoing EU RMP category 2 THE ALPHA-MANNOSIDOSIS REGISTRY: A multi-centre, multi-country, non interventional, prospective cohort, in alpha-mannosidosis patients (SPARKLE) Yes No
29223 Ongoing Not included in RMP Effectiveness of Fostair® (ICS/LABA) vs. dual bronchodilation (LABA/LAMA) in COPD (FELICITI) No No
35491 Ongoing Not included in RMP A MULTICENTRE, NON-INTERVENTIONAL, RETROSPECTIVE STUDY TO EXPLORE THE EFFECTS OF TRANSITIONING FROM IMMEDIATE RELEASE TO EXTENDED RELEASE ORAL... No No
36393 Ongoing EU RMP category 3 A multicentre observational, prospective cohort study including patients with acute coronary syndromes undergoing percutaneous coronary intervention... No No
39039 Ongoing Not included in RMP CharacTeristics of treAtment response to hIgh dose ICS/LABA vs. Medium or high dOse ICS/LABA + LAMA in patients with uncontRolled moderate to severe... No No
39494 Finalised Not included in RMP Expert opinion on the impact of inhaler choice on climate change and personalised healthcare Yes No
47420 Planned EU RMP category 3 MulTinational database cohoRt study to assess adverse cardIovascular and cereBrovascular outcomes in patiEnts (TRIBE) with chronic obstructive... No No
106491 Planned Not included in RMP Patient characteristics and treatment pathways in patients with COPD initiated on ICS/LABA/LAMA and LABA/LAMA treatment No No

PAS by Risk Management Plan (RMP) requirement

Chiesi Farmaceutici

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.