Research in Real Life (RIRL)

This sponsor has funded 17 studies across 10 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
4238 Finalised Not included in RMP A RETROSPECTIVE, REAL-LIFE EVALUATION OF THE CARDIOVASCULAR DISEASE RISK ASSOCIATED WITH EXPOSURE TO PHARMACOLOGICAL SMOKING CESSATION INTERVENTIONS... Yes No
4860 Finalised Not included in RMP Validation of real-life asthma research endpoints (Real-life asthma endpoint validation) Yes No
4869 Finalised Not included in RMP Using real-life patient records to help identify predictors of future exacerbation risk (Asthma risk predictors) Yes No
4872 Finalised Unspecified Real-life effectiveness (and cost impact) evaluation of fixed-dose combination fluticasone propionate/formoterol (Flutiform®) for the management of... Yes Yes
4921 Finalised Not included in RMP THE RELIABILITY AND UTILITY OF BLOOD EOSINOPHILS AS A MARKER OF DISEASE BURDEN, HEALTHCARE RESOURCE UTILISATION IN CHRONIC OBSTRUCTIVE PULMONARY... Yes No
6573 Finalised Unspecified Real-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK... Yes Yes
6804 Finalised Unspecified Metabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes Yes No
7641 Finalised Unspecified Real-life effectiveness (and cost impact) evaluation of fixed-dose combination fluticasone propionate/formoterol (Flutiform®) for the management of... Yes Yes
8019 Finalised Unspecified Characterising patients at risk of failed Diskus use in primary care Yes No
9105 Ongoing Not included in RMP Real-world effectiveness of extra-fine formulations in Denmark No No
9651 Finalised Not included in RMP CRITIKAL Study Yes No
10483 Finalised Unspecified Increasing ICS Dose vs Add-on Therapy in Children with Asthma (Paediatric Asthma Step-up) Yes No
11387 Finalised Not included in RMP Underuse of beta-blockers in patients with heart failure and COPD No No
12275 Finalised Not included in RMP Real-life effectiveness evaluation of changing inhaler device for asthma treatment in Korea (Transfform) Yes No
12279 Finalised Not included in RMP Real-life effectiveness evaluation of asthma treatment in Korea Yes Yes
12631 Finalised Not included in RMP Real life effectiveness and cost impact evaluation of fixed dose combination fluticasone propionate/formoterol (Flutiform®) compared to fluticasone... Yes Yes
13586 Finalised Not included in RMP Does the cost of inhaler devices affect therapy adherence and disease outcomes? Yes Yes

PAS by Risk Management Plan (RMP) requirement

Research in Real Life (RIRL)

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.