Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment with a Combination of Inhaled Corticosteroids and Long-acting β2 agonists in COPD patients

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39824
• EU PAS number:
  EUPAS35014
• Study ID:
  39824
• Official title and acronym:
  Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment with a Combination of Inhaled Corticosteroids and Long-acting β2 agonists in COPD patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The goal of this study is to compare patients treated with Tio+Olo with patients treated with LABA/ICS combination therapy in terms of COPD exacerbation risk, pneumonia risk, escalation to triple therapy and healthcare utilization, and to determine whether there is variation by history of COPD exacerbation and circulating eosinophil levels.
• Study status:
  Finalised

Research institution and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned: 22/05/2019

Actual: 22/05/2019

Study start date

Planned: 01/11/2019

Actual: 01/11/2019

Date of final study report

Planned: 31/08/2020

Actual: 16/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer-Ingelheim

Study protocol

Initial protocol

1237-0093_CTP_final-rule_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT04138758