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

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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).

Key facts

Study ID

NCT01431274

Run by

Boehringer Ingelheim

People needed

2624

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2015-07-16

Who can join

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

You may qualify if…

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

You may not qualify if…

• Significant disease other than COPD
• Clinically relevant abnormal lab values.
• History of asthma.
• Diagnosis of thyrotoxicosis
• Diagnosis of paroxysmal tachycardia
• History of myocardial infarction within 1 year of screening visit
• Unstable or life-threatening cardiac arrhythmia.
• Hospitalization for heart failure within the past year.
• Known active tuberculosis.
• Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• History of life-threatening pulmonary obstruction.
• History of cystic fibrosis.
• Clinically evident bronchiectasis.
• History of significant alcohol or drug abuse.
• Thoracotomy with pulmonary resection
• Oral ß-adrenergics.
• Oral corticosteroid medication at unstable doses
• Regular use of daytime oxygen therapy for more than one hour per day
• Pulmonary rehabilitation program in the six weeks prior to the screening visit
• Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
• Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
• Pregnant or nursing women.
• Women of childbearing potential not using a highly effective method of birth control
• Patients who are unable to comply with pulmonary medication restrictions

Where it is running

• 1237.5.01036 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1237.5.01015 Boehringer Ingelheim Investigational Site — Boulder, Colorado, United States
• 1237.5.01024 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1237.5.01034 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1237.5.01003 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.5.01010 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.5.01027 Boehringer Ingelheim Investigational Site — Panama City, Florida, United States
• 1237.5.01031 Boehringer Ingelheim Investigational Site — O'Fallon, Illinois, United States
• 1237.5.01035 Boehringer Ingelheim Investigational Site — Opelousas, Louisiana, United States
• 1237.5.01004 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 1237.5.01017 Boehringer Ingelheim Investigational Site — Biddeford, Maine, United States
• 1237.5.01028 Boehringer Ingelheim Investigational Site — Columbia, Maryland, United States
• 1237.5.01013 Boehringer Ingelheim Investigational Site — Livonia, Michigan, United States
• 1237.5.01019 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1237.5.01025 Boehringer Ingelheim Investigational Site — Larchmont, New York, United States
• 1237.5.01008 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
• 1237.5.01023 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 1237.5.01016 Boehringer Ingelheim Investigational Site — Tabor City, North Carolina, United States
• 1237.5.01006 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1237.5.01040 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1237.5.01039 Boehringer Ingelheim Investigational Site — Dayton, Ohio, United States
• 1237.5.01037 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
• 1237.5.01009 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1237.5.01032 Boehringer Ingelheim Investigational Site — Charleston, Pennsylvania, United States
• 1237.5.01038 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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