Status: Finalised First registered on: 29/09/2010
Last updated on: 30/03/2015
1. Study identification
EU PAS Register NumberEUPAS1578
Official titleLong-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised patients with Chronic Obstructive Pulmonary Disease (COPD) - a cohort study based on health information systems in three Italian regions.
Study title acronymOUTPUL
Study typeObservational study
Brief description of the studyObjectives: to measure long-term outcomes and adverse events of inhaled drugs in COPD patients; to compare effectiveness of the different drugs (mono- and polytherapy) in terms of long-term survival or exacerbations; to compare incidence of side effects of inhaled therapy among users vs non-users. Design: patients discharged with COPD in 2006-07 will be enrolled from the Hospital Information Systems (HIS) and record linkage performed with mortality, hospital, emergency and drug claims data to define exposure (ICS, LABA, and anticholinergics), potential confounders, and to measure outcomes over 4 years. Outcomes: all-cause, respiratory and cardiovascular mortality, incidence of adverse events, and COPD exacerbations. Cox-proportional-hazard models will be applied to compare outcomes in users vs non-users of exposure to different drug groups (mono-/polytherapy). Sensitivity analyses will take into account different subgroup susceptibility or different definitions of chronic exposure.
Was this study requested by a regulator?Yes:
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsDepartment of Epidemiology Lazio Region, Italy
Department/Research groupClinical Epidemiological Unit
Organisation/affiliationDepartment of Epidemiology
Website/Homepagewww.deplazio.net
Details of (Primary) lead investigator
Title Dr
Last name Agabiti
First name Nera
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

ASSR Emilia-Romagna
Epidemiologic Observatory of the Health Directorate of the Lombardy region, Milan, Italy
Respiratory Physiology Unit in the Columbus Hospital, Catholic University, Rome, Italy
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/201016/06/2010
Start date of data collection15/09/201015/09/2010
Start date of data analysis01/01/201202/01/2012
Date of interim report, if expected31/12/201131/12/2011
Date of final study report01/06/201301/06/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyAIFA (Italian Medicines Agency)50
Research councils
EU funding scheme
OtherParticipating centres50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Agabiti
First name Nera
Address line 1Via Santa Costanza 53
Address line 2 
Address line 3 
CityRoma 
Postcode00198 
CountryItaly
Phone number (incl. country code)390683060421 
Alternative phone number 
Fax number (incl. country code)390683060374 
Email address u.kirchmayer@deplazio.it
Public Enquiries
Title Dr 
Last name Agabiti 
First name Nera 
Address line 1Via Santa Costanza 53 
Address line 2 
Address line 3 
CityRoma 
Postcode00198 
CountryItaly 
Phone number (incl. country code)390683060421 
Alternative phone number 
Fax number (incl. country code)390683060374 
Email address u.kirchmayer@deplazio.it 
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