Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in comparison to Maintenance Treatment with a Combination of Inhaled Corticosteroids, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients

Study identification

• EU PAS number:
  EUPAS31932
• Study ID:
  31933
• 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, Long-acting β2 Agonists and Long-acting Muscarinic Antagonists in COPD Patients
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The treatment of COPD involves multiple therapies, including long-acting β2 agonists (LABA) (with and without inhaled corticosteroids (ICS) and long-acting muscarinic antagonists (LAMA), with combinations of these drugs now formulated into single inhalers. There are recommendations to restrict triple therapy use further, to only patients who are likely to respond to ICS (such as those with asthma-COPD overlap or patients with high risk of exacerbations and elevated blood eosinophils. There is an increasing body of evidence suggesting that ICS are particularly effective at reducing the incidence of COPD exacerbations in patients only with a very high blood eosinophil concentration, but not in normal levels. Hence there is a clear need for better evidence on specific patient populations upon which to base treatment recommendations. This non-interventional study aims to assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open).
• Study status:
  Planned

Research institutions 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

Date of final study report

Planned:21/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer ingelheim International GmbH

Regulatory

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