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 COPD.

Key facts

Study ID

NCT01431287

Run by

Boehringer Ingelheim

People needed

2539

Starts

2011-09-01

Expected to finish

2013-11-01

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

• 1237.6.01120 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• 1237.6.01131 Boehringer Ingelheim Investigational Site — Danbury, Connecticut, United States
• 1237.6.01117 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1237.6.01118 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1237.6.01126 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1237.6.01109 Boehringer Ingelheim Investigational Site — Winter Park, Florida, United States
• 1237.6.01134 Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• 1237.6.01107 Boehringer Ingelheim Investigational Site — Couer d'Alene, Idaho, United States
• 1237.6.01110 Boehringer Ingelheim Investigational Site — Lafayette, Louisiana, United States
• 1237.6.01128 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 1237.6.01130 Boehringer Ingelheim Investigational Site — North Dartmouth, Massachusetts, United States
• 1237.6.01104 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
• 1237.6.01116 Boehringer Ingelheim Investigational Site — Plymouth, Minnesota, United States
• 1237.6.01121 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1237.6.01123 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1237.6.01129 Boehringer Ingelheim Investigational Site — Henderson, Nevada, United States
• 1237.6.01136 Boehringer Ingelheim Investigational Site — Marlton, New Jersey, United States
• 1237.6.01108 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
• 1237.6.01127 Boehringer Ingelheim Investigational Site — Bayside, New York, United States
• 1237.6.01139 Boehringer Ingelheim Investigational Site — Great Neck, New York, United States
• 1237.6.01135 Boehringer Ingelheim Investigational Site — Charlotte, North Carolina, United States
• 1237.6.01114 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1237.6.01102 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1237.6.01115 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1237.6.01106 Boehringer Ingelheim Investigational Site — Greer, California, United States

Full record on ClinicalTrials.gov

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