Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT01431274. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01431274
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,624 participants
Conditions and interventions
Conditions
Interventions
- tiotropium + olodaterol Drug
- tiotropium Drug
- olodaterol Drug
- Respimat Device
Drug · Device
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Aug 31, 2013
- Completion
- Aug 31, 2013
- Last update posted
- Jul 15, 2015
2011 – 2013
United States locations
- U.S. sites
- 35
- U.S. states
- 21
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1237.5.01038 Boehringer Ingelheim Investigational Site | Jasper | Alabama | — | — |
| 1237.5.01036 Boehringer Ingelheim Investigational Site | Mobile | Alabama | — | — |
| 1237.5.01015 Boehringer Ingelheim Investigational Site | Boulder | Colorado | — | — |
| 1237.5.01024 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado | — | — |
| 1237.5.01034 Boehringer Ingelheim Investigational Site | Stamford | Connecticut | — | — |
| 1237.5.01003 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1237.5.01010 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1237.5.01027 Boehringer Ingelheim Investigational Site | Panama City | Florida | — | — |
| 1237.5.01031 Boehringer Ingelheim Investigational Site | O'Fallon | Illinois | — | — |
| 1237.5.01035 Boehringer Ingelheim Investigational Site | Opelousas | Louisiana | — | — |
| 1237.5.01004 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana | — | — |
| 1237.5.01017 Boehringer Ingelheim Investigational Site | Biddeford | Maine | — | — |
| 1237.5.01028 Boehringer Ingelheim Investigational Site | Columbia | Maryland | — | — |
| 1237.5.01013 Boehringer Ingelheim Investigational Site | Livonia | Michigan | — | — |
| 1237.5.01019 Boehringer Ingelheim Investigational Site | Omaha | Nebraska | — | — |
| 1237.5.01025 Boehringer Ingelheim Investigational Site | Larchmont | New York | — | — |
| 1237.5.01008 Boehringer Ingelheim Investigational Site | Rochester | New York | — | — |
| 1237.5.01023 Boehringer Ingelheim Investigational Site | Raleigh | North Carolina | — | — |
| 1237.5.01016 Boehringer Ingelheim Investigational Site | Tabor City | North Carolina | — | — |
| 1237.5.01006 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1237.5.01040 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1237.5.01039 Boehringer Ingelheim Investigational Site | Dayton | Ohio | — | — |
| 1237.5.01037 Boehringer Ingelheim Investigational Site | Toledo | Ohio | — | — |
| 1237.5.01009 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1237.5.01032 Boehringer Ingelheim Investigational Site | Charleston | Pennsylvania | — | — |
| 1237.5.01005 Boehringer Ingelheim Investigational Site | Johnston | Rhode Island | — | — |
| 1237.5.01021 Boehringer Ingelheim Investigational Site | Easley | South Carolina | — | — |
| 1237.5.01012 Boehringer Ingelheim Investigational Site | Gaffney | South Carolina | — | — |
| 1237.5.01014 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | — | — |
| 1237.5.01029 Boehringer Ingelheim Investigational Site | Fort Worth | Texas | — | — |
| 1237.5.01002 Boehringer Ingelheim Investigational Site | San Antonio | Texas | — | — |
| 1237.5.01026 Boehringer Ingelheim Investigational Site | Lynchburg | Virginia | — | — |
| 1237.5.01007 Boehringer Ingelheim Investigational Site | Spokane | Washington | — | — |
| 1237.5.01033 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
| 1237.5.01001 Boehringer Ingelheim Investigational Site | Morgantown | West Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 204 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01431274, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 15, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01431274 live on ClinicalTrials.gov.