Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

Primary Outcome

FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1). The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) inc

Conditions Studied

Pulmonary Disease, Chronic Obstructive

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
Boehringer Ingelheim

515 total trials

What the finished NCT01431274 record still lists

NCT01431274 is an interventional study that assigns participants to a tested intervention. Its 2,624 participants enrollment target places it among the larger protocols in the corpus, above the 1,009-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (160% higher).

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 names 20 study sites across 13 states, led by 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.

Learn More About Clinical Trials

Similar trials for Pulmonary Disease, Chronic Obstructive

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01431274's enrollment target sits among peer trials

2,624 8th of 74 higher than 67 of 74 other Pulmonary Disease, Chronic Obstructive trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06455085 · 2,634 participants · NA

    RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE

  • NCT06033950 · 2,600 participants · Phase 3

    A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

  • NCT06574672 · 2,600 participants · NA

    Embedded Palliative Care in the MICU

  • NCT06825715 · 2,653 participants · NA

    Multilevel Intervention for Precision Oncology

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT01431274, the US trial registry maintained by the National Library of Medicine. NCT01431274 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.