Long-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 (OUTPUL)

Study identification

• EU PAS number:
  EUPAS1578
• Study ID:
  9133
• Official title and acronym:
  Long-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 (OUTPUL)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Objectives: 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Epidemiology of the Regional Health Service - Lazio

Italy

Emilia-Romagna Health and Social Agency (ASSR Emilia-Romagna)

Italy

Epidemiologic Observatory of the Health Directorate of the Lombardy region, Milan, Italy, Respiratory Physiology Unit in the Columbus Hospital, Catholic University, Rome, Italy

Study timelines

Date when funding contract was signed

Planned: 01/06/2010

Actual: 16/06/2010

Study start date

Planned: 15/09/2010

Actual: 15/09/2010

Data analysis start date

Planned: 01/01/2012

Actual: 02/01/2012

Date of interim report, if expected

Planned: 31/12/2011

Actual: 31/12/2011

Date of final study report

Planned: 01/06/2013

Actual: 01/06/2014

Sources of funding

Other

More details on funding

AIFA (Italian Medicines Agency), Participating centres

Regulatory

• Was the study required by a regulatory body?:
  Yes