chronic obstructive pulmonary disease MedDRA version: 17.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Tiotropium 2.5µg/Olodaterol 2.5µg
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: tiotropium bromide
CAS Number: 186691-13-4
Other descriptive name: TIOTROPIUM
Concentratio
Sponsors
Boehringer Ingelheim Italia S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients, 40 years of age or older. - Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)=65 years) yes F.1.3.1 Number of subjects for this age range 7000
Exclusion criteria
Exclusion criteria: - Significant disease other than COPD. - Clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine > x2 ULN will be excluded regardless of clinical condition - Current documented history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma - A diagnosis of thyrotoxicosis - A history of myocardial infarction within 6 months of screening visit. - Life-threatening cardiac arrhythmia. - Known active tuberculosis. - Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed). - A history of cystic fibrosis. - Clinically relevant bronchiectasis. - Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening - A history of significant alcohol or drug abuse in the opinion of the investigator. - Patients who have undergone thoracotomy with pulmonary resection - Patients being treated with oral or patch ß-adrenergics. - Patients being treated with oral corticosteroid medication at unstable doses - Patients being treated with PDE4 inhibitors within 3 months of screening visit - Patients who have taken an investigational drug within one month or six half-lives - Pregnant or nursing women. - Women of childbearing potential not using a highly effective method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of Tiotropium + Olodaterol on COPD exacerbations;Secondary Objective: To compare the effect of Tiotropium + Olodaterol on hospitalisation associated with exacerbations and survival;Primary end point(s): 1: Primary endpoint: annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date). ;Timepoint(s) of evaluation of this end point: 1: 52 weeks + 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Key secondary endpoint: time to first moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date). 2: Time to all-cause mortality (within 1 day after the last drug administration date). 3: Annualised rate of exacerbation leading to hospitalisation during the treatment period (within 1 day after the last drug administration date). 4: Time to first COPD exacerbations leading to hospitalisation during the treatment period (within 1 day after the last drug administration date). ;Timepoint(s) of evaluation of this end point: 1: 52 weeks + 1 day 2: 52 weeks + 1 day 3: 52 weeks + 1 day 4: 52 weeks + 1 day | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed