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NCT04184297 · ClinicalTrials.gov registry record
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy
A clinical trial, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- 27,190
- Enrollment target
NCT04184297: Completed study, sponsored by Boehringer Ingelheim.
NCT04184297 is a clinical trial that has completed, run by Boehringer Ingelheim. The registered enrollment target is 27,190 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04184297 has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- 27,190 participants
- Enrollment target
Study 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
Primary Outcome
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Interventions
- DRUG Tiotropium and Olodaterol (Tio+Olo)
- DRUG Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27,190 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2019-11-04 |
What the finished NCT04184297 record still lists
NCT04184297 is an observational study that tracks outcomes without assigning an intervention. Its 27,190 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Tiotropium and Olodaterol (Tio+Olo) is the first listed.
NCT04184297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04184297 about?
NCT04184297 is a clinical study titled "Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy". 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
What is the current status of trial NCT04184297?
This trial is currently completed. The enrollment target is 27,190 participants. The study started on 2019-11-01. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT04184297?
The interventions under investigation include: Tiotropium and Olodaterol (Tio+Olo) (DRUG), Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS) (DRUG).
Who is sponsoring clinical trial NCT04184297?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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