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

COMPLETED Phase 3

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

NCT01431274 · View on ClinicalTrials.gov ↗

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

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01431274

The ClinicalTrials.gov registry entry for NCT01431274 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,624 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01431274 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Alabama, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01431274?

The interventions under investigation include: tiotropium + olodaterol (DRUG), tiotropium (DRUG), olodaterol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01431274?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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