A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium (high dose) + Olodaterol; Tiotropium (low dose) + Olodaterol
Intervention description: Tiotropium + Olodaterol solution for inhalation; Tiotropium + Olodaterol solution for inhalation
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol
      fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3
      weeks once daily treatment in Japanese patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of chronic obstructive pulmonary disease

          2. Relatively stable airway obstruction with post FEV1=<30% of predicted normal and< 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. A marked baseline prolongation of QT/QTc interval

          7. A history of additional risk factors for Torsade de Pointes (TdP)

          8. History of myocardial infarction within 1 year of screening visit

          9. Unstable or life-threatening cardiac arrhythmia

         10. Hospitalization for heart failure within the past year

         11. Known active tuberculosis

         12. Malignancy for which patient has undergone resection, radiation therapy or
             chemotherapy within last five years

         13. History of life-threatening pulmonary obstruction

         14. History of cystic fibrosis

         15. Clinically evident bronchiectasis

         16. History of significant alcohol or drug abuse

         17. Thoracotomy with pulmonary resection

         18. Oral ß-adrenergics

         19. Oral corticosteroid medication at unstable doses

         20. Regular use of daytime oxygen therapy for more than one hour per day

         21. Pulmonary rehabilitation program in the six weeks prior to the screening visit

         22. Investigational drug within one month or six half lives (whichever is greater) prior
             to screening visit

         23. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA

         24. Pregnant or nursing women

         25. Women of childbearing potential not using a highly effective method of birth control

         26. Patients who have previously been randomized in this study or are currently
             participating in another study

         27. Patients who are unable to comply with pulmonary medication restrictions

         28. Patients with narrow-angle glaucoma or micturition disorder due to prostatic
             hyperplasia etc

         29. Patients being treated with medications that prolong the QT/QTc interval