Trials / Completed
CompletedNCT04138758
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 42,953 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation. Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tiotropium bromide + Olodaterol | Tiotropium bromide + Olodaterol |
| DRUG | LABA/ICS | Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) |
Timeline
- Start date
- 2019-11-01
- Primary completion
- 2019-11-04
- Completion
- 2019-11-04
- First posted
- 2019-10-24
- Last updated
- 2021-11-15
- Results posted
- 2020-11-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04138758. Inclusion in this directory is not an endorsement.