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NCT04223843 · ClinicalTrials.gov registry record · Phase 4
A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 213
- Enrollment target
NCT04223843: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT04223843 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 213 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223843, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 213 participants
- Enrollment target
Study Summary
To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is based on the Global Initiative for Chronic Lung Disease (GOLD) guidelines (GOLD 2 - 3)
Primary Outcome
FEV1 AUC0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in liters. Mean is adjusted mean. A hierarchical testing procedure was used to test the primary endpoint. Each of the tests were considered confirmatory only if all previous tests were successful.
Interventions
- DRUG Placebo
- DRUG Tiotropium + olodaterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2020-09-29 |
| Phase | Phase 4 |
What the finished NCT04223843 record still lists
NCT04223843 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04223843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04223843 about?
NCT04223843 is a clinical study titled "A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale". To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is based on the Global ...
What is the current status of trial NCT04223843?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 213 participants. The study started on 2020-01-08. Estimated completion is 2020-09-29.
What interventions are being tested in trial NCT04223843?
The interventions under investigation include: Placebo (DRUG), Tiotropium + olodaterol (DRUG).
Who is sponsoring clinical trial NCT04223843?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04223843's enrollment target sits among peer trials
213 396th of 2000 higher than 1,605 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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