Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

Key facts

Study ID

NCT02006732

Run by

Boehringer Ingelheim

People needed

809

Starts

2013-11-01

Expected to finish

2014-11-01

Last updated by the study team

2016-01-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis chronic obstructive pulmonary disease
• Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70%
• Male or female patients, 40 years of age or more
• Smoking history more than 10 pack years

You may not qualify if…

• Significant diseases other than COPD
• History of asthma
• COPD exacerbation in previous 3 months
• Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
• Pregnant or nursing women
• Patients unable to comply with pulmonary medication restrictions

Where it is running

• 1237.26.10618 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1237.26.10619 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.26.10614 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1237.26.10616 Boehringer Ingelheim Investigational Site — Duluth, Georgia, United States
• 1237.26.10613 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1237.26.10615 Boehringer Ingelheim Investigational Site — Greensboro, North Carolina, United States
• 1237.26.10603 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1237.26.10621 Boehringer Ingelheim Investigational Site — Dayton, Ohio, United States
• 1237.26.10612 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
• 1237.26.10605 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1237.26.10606 Boehringer Ingelheim Investigational Site — Medford, Oregon, United States
• 1237.26.10610 Boehringer Ingelheim Investigational Site — East Providence, Rhode Island, United States
• 1237.26.10607 Boehringer Ingelheim Investigational Site — Gaffney, South Carolina, United States
• 1237.26.10617 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
• 1237.26.10608 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1237.26.10604 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
• 1237.26.10609 Boehringer Ingelheim Investigational Site — Boerne, Texas, United States
• 1237.26.10602 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1237.26.10601 Boehringer Ingelheim Investigational Site — Morgantown, West Virginia, United States
• 1237.26.61004 Boehringer Ingelheim Investigational Site — Concord, New South Wales, Australia
• 1237.26.61002 Boehringer Ingelheim Investigational Site — Daw Park, South Australia, Australia
• 1237.26.61003 Boehringer Ingelheim Investigational Site — Toorak Gardens, South Australia, Australia
• 1237.26.61007 Boehringer Ingelheim Investigational Site — Woodville, South Australia, Australia
• 1237.26.61005 Boehringer Ingelheim Investigational Site — Murdoch, Western Australia, Australia
• 1237.26.10620 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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