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NCT04138758 · ClinicalTrials.gov registry record
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS
A clinical trial, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- 42,953
- Enrollment target
NCT04138758: Completed study, sponsored by Boehringer Ingelheim.
NCT04138758 is a clinical trial that has completed, run by Boehringer Ingelheim. The registered enrollment target is 42,953 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138758 has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- 42,953 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid.
Interventions
- DRUG Tiotropium bromide + Olodaterol
- DRUG LABA/ICS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42,953 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2019-11-04 |
What the finished NCT04138758 record still lists
NCT04138758 is an observational study that tracks outcomes without assigning an intervention. Its 42,953 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 bromide + Olodaterol is the first listed.
NCT04138758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04138758 about?
NCT04138758 is a clinical study titled "Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS". 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...
What is the current status of trial NCT04138758?
This trial is currently completed. The enrollment target is 42,953 participants. The study started on 2019-11-01. Estimated completion is 2019-11-04.
What interventions are being tested in trial NCT04138758?
The interventions under investigation include: Tiotropium bromide + Olodaterol (DRUG), LABA/ICS (DRUG).
Who is sponsoring clinical trial NCT04138758?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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