Status:
COMPLETED
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
2624 Patients enrolled
Trial Details
Trial ID
NCT01431274
Start Date
September 1 2011
End Date
September 1 2013
Last Update
July 16 2015
Active Locations (239)
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1
1237.5.01038 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
2
1237.5.01036 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
3
1237.5.01015 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
4
1237.5.01024 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States