NCT04184297

Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27,190 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Tiotropium and Olodaterol (Tio+Olo)	drug
DRUG	Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)	drug

Timeline

• Start date: 2019-11-01
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2019-12-03
• Last updated: 2021-11-15
• Results posted: 2020-11-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study