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NCT01431274 · ClinicalTrials.gov registry record · Phase 3

Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
2,624
Enrollment target
20
Study locations

NCT01431274 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,624 participants, above the 1,009-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (160% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT01431274, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
2,624 participants
Enrollment target
20
Study locations

Study Summary

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Interventions

  • DRUG tiotropium + olodaterol
  • DRUG tiotropium
  • DRUG olodaterol

Study Locations (20)

Florida

  • 1237.5.01003 Boehringer Ingelheim Investigational Site - Clearwater
  • 1237.5.01010 Boehringer Ingelheim Investigational Site - Clearwater
  • 1237.5.01027 Boehringer Ingelheim Investigational Site - Panama City

Alabama

  • 1237.5.01038 Boehringer Ingelheim Investigational Site - Jasper
  • 1237.5.01036 Boehringer Ingelheim Investigational Site - Mobile

Colorado

  • 1237.5.01015 Boehringer Ingelheim Investigational Site - Boulder
  • 1237.5.01024 Boehringer Ingelheim Investigational Site - Wheat Ridge

Louisiana

  • 1237.5.01035 Boehringer Ingelheim Investigational Site - Opelousas
  • 1237.5.01004 Boehringer Ingelheim Investigational Site - Shreveport

New York

  • 1237.5.01025 Boehringer Ingelheim Investigational Site - Larchmont
  • 1237.5.01008 Boehringer Ingelheim Investigational Site - Rochester

North Carolina

  • 1237.5.01023 Boehringer Ingelheim Investigational Site - Raleigh
  • 1237.5.01016 Boehringer Ingelheim Investigational Site - Tabor City

Connecticut

  • 1237.5.01034 Boehringer Ingelheim Investigational Site - Stamford

Illinois

  • 1237.5.01031 Boehringer Ingelheim Investigational Site - O'Fallon

Trial Details

FieldValue
Enrollment Target 2,624 participants
Start Date 2011-09
Est. Completion 2013-09
Phase Phase 3

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT01431274

The ClinicalTrials.gov registry entry for NCT01431274 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,624 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,009-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (160% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 3 interventions - of which tiotropium + olodaterol is the first listed.

NCT01431274 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Alabama, Colorado.

Frequently Asked Questions

What is clinical trial NCT01431274 about?

NCT01431274 is a clinical study titled "Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)". The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patie...

What is the current status of trial NCT01431274?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,624 participants. The study started on 2011-09. Estimated completion is 2013-09.

What conditions does trial NCT01431274 study?

This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.

What interventions are being tested in trial NCT01431274?

The interventions under investigation include: tiotropium + olodaterol (DRUG), tiotropium (DRUG), olodaterol (DRUG).

Who is sponsoring clinical trial NCT01431274?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01431274 being conducted?

This trial has 20 study locations across Alabama, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.