Japan Long-term Safety for Tiotropium Plus Olodaterol
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium + Olodaterol; Respimat; Tiotropium + Olodaterol; Olodaterol; Respimat; Respimat
Intervention description: Tiotropium and Olodaterol FDC once daily inhalation; Respimat inhaler; Tiotropium and Olodaterol FDC once daily inhalation; Olodaterol once daily inhalation; Respimat inhaler; Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 122.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the safety of 52 weeks once daily treatment
      with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT
      Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of chronic obstructive pulmonary disease.

          2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post
             FEV1/FVC <70%.

          3. Male or female Japanese patients, 40 years of age or older.

          4. Smoking history of more than 10 pack years.

        Exclusion criteria:

          1. Significant disease other than COPD

          2. Clinically relevant abnormal lab values.

          3. History of asthma.

          4. Diagnosis of thyrotoxicosis

          5. Diagnosis of paroxysmal tachycardia

          6. History of myocardial infarction within 1 year of screening visit

          7. Unstable or life-threatening cardiac arrhythmia.

          8. Hospitalization for heart failure within the past year.

          9. Known active tuberculosis.

         10. Malignancy for which patient has undergone resection, radiation therapy or
             chemotherapy within last five years

         11. History of life-threatening pulmonary obstruction.

         12. History of cystic fibrosis.

         13. Clinically evident bronchiectasis.

         14. History of significant alcohol or drug abuse.

         15. Thoracotomy with pulmonary resection

         16. Oral ß-adrenergics.

         17. Oral corticosteroid medication at unstable doses

         18. Regular use of daytime oxygen therapy for more than one hour per day

         19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

         20. Investigational drug within one month or six half lives (whichever is greater) prior
             to screening visit

         21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA

         22. Pregnant or nursing women.

         23. Women of childbearing potential not using a highly effective method of birth control

         24. Patients who are unable to comply with pulmonary medication restrictions

         25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic
             hyperplasia etc.