Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT01431287. 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 2]
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 COPD.
Study identification
- NCT ID
- NCT01431287
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,539 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
- Oct 31, 2013
- Completion
- Oct 31, 2013
- Last update posted
- Jul 15, 2015
2011 – 2013
United States locations
- U.S. sites
- 38
- U.S. states
- 24
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1237.6.01106 Boehringer Ingelheim Investigational Site | Greer | California | — | — |
| 1237.6.01120 Boehringer Ingelheim Investigational Site | Fort Collins | Colorado | — | — |
| 1237.6.01131 Boehringer Ingelheim Investigational Site | Danbury | Connecticut | — | — |
| 1237.6.01117 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut | — | — |
| 1237.6.01118 Boehringer Ingelheim Investigational Site | DeLand | Florida | — | — |
| 1237.6.01126 Boehringer Ingelheim Investigational Site | Tampa | Florida | — | — |
| 1237.6.01109 Boehringer Ingelheim Investigational Site | Winter Park | Florida | — | — |
| 1237.6.01134 Boehringer Ingelheim Investigational Site | Atlanta | Georgia | — | — |
| 1237.6.01107 Boehringer Ingelheim Investigational Site | Couer d'Alene | Idaho | — | — |
| 1237.6.01110 Boehringer Ingelheim Investigational Site | Lafayette | Louisiana | — | — |
| 1237.6.01128 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1237.6.01130 Boehringer Ingelheim Investigational Site | North Dartmouth | Massachusetts | — | — |
| 1237.6.01104 Boehringer Ingelheim Investigational Site | Minneapolis | Minnesota | — | — |
| 1237.6.01116 Boehringer Ingelheim Investigational Site | Plymouth | Minnesota | — | — |
| 1237.6.01121 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1237.6.01123 Boehringer Ingelheim Investigational Site | St Louis | Missouri | — | — |
| 1237.6.01129 Boehringer Ingelheim Investigational Site | Henderson | Nevada | — | — |
| 1237.6.01136 Boehringer Ingelheim Investigational Site | Marlton | New Jersey | — | — |
| 1237.6.01108 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1237.6.01127 Boehringer Ingelheim Investigational Site | Bayside | New York | — | — |
| 1237.6.01139 Boehringer Ingelheim Investigational Site | Great Neck | New York | — | — |
| 1237.6.01135 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 1237.6.01114 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | — | — |
| 1237.6.01102 Boehringer Ingelheim Investigational Site | Columbus | Ohio | — | — |
| 1237.6.01115 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma | — | — |
| 1237.6.01101 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | — | — |
| 1237.6.01113 Boehringer Ingelheim Investigational Site | East Providence | Rhode Island | — | — |
| 1237.6.01122 Boehringer Ingelheim Investigational Site | Charleston | South Carolina | — | — |
| 1237.6.01132 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | — | — |
| 1237.6.01137 Boehringer Ingelheim Investigational Site | Greenville | South Carolina | — | — |
| 1237.6.01111 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | — | — |
| 1237.6.01105 Boehringer Ingelheim Investigational Site | Union | South Carolina | — | — |
| 1237.6.01138 Boehringer Ingelheim Investigational Site | Killeen | Texas | — | — |
| 1237.6.01124 Boehringer Ingelheim Investigational Site | McKinney | Texas | — | — |
| 1237.6.01112 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
| 1237.6.01133 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
| 1237.6.01125 Boehringer Ingelheim Investigational Site | Spokane | Washington | — | — |
| 1237.6.01103 Boehringer Ingelheim Investigational Site | Tacoma | Washington | — | — |
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 202 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01431287, 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 NCT01431287 live on ClinicalTrials.gov.