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To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.
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Ages Eligible for Study:
55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Incident new-user cohort design with high-dimensional propensity scores to match the two comparison groups of COPD.
New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at forst maintenance inhaler.
Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:
find information in order to request access to clinical study data, for listed studies.
request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.