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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.

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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

FieldValue
Enrollment Target 27,190 participants
Start Date 2019-11-01
Est. Completion 2019-11-04
Boehringer Ingelheim

515 total trials

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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Source: ClinicalTrials.gov NCT04184297, the US trial registry maintained by the National Library of Medicine. NCT04184297 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.