Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

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

NCT01964352

Run by

Boehringer Ingelheim

People needed

813

Starts

2013-11-01

Expected to finish

2014-11-01

Last updated by the study team

2015-11-25

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

• 1237.25.10507 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.25.10517 Boehringer Ingelheim Investigational Site — Panama City, Florida, United States
• 1237.25.10505 Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• 1237.25.10516 Boehringer Ingelheim Investigational Site — Ann Arbor, Michigan, United States
• 1237.25.10509 Boehringer Ingelheim Investigational Site — Livonia, Michigan, United States
• 1237.25.10519 Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
• 1237.25.10503 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1237.25.10518 Boehringer Ingelheim Investigational Site — Columbia, Ohio, United States
• 1237.25.10502 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1237.25.10511 Boehringer Ingelheim Investigational Site — Dublin, Ohio, United States
• 1237.25.10514 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1237.25.10513 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1237.25.10515 Boehringer Ingelheim Investigational Site — Easley, South Carolina, United States
• 1237.25.10506 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
• 1237.25.10501 Boehringer Ingelheim Investigational Site — Rock Hill, South Carolina, United States
• 1237.25.10508 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1237.25.10520 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
• 1237.25.10510 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1237.25.10521 Boehringer Ingelheim Investigational Site — Spokane, Washington, United States
• 1237.25.32001 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1237.25.32004 Boehringer Ingelheim Investigational Site — Brussels, Belgium
• 1237.25.32005 Boehringer Ingelheim Investigational Site — Eupen, Belgium
• 1237.25.32003 Boehringer Ingelheim Investigational Site — Lebbeke, Belgium
• 1237.25.32002 Boehringer Ingelheim Investigational Site — Turnhout, Belgium
• 1237.25.10504 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States

Full record on ClinicalTrials.gov

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