Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium + olodaterol; tiotropium; olodaterol; tiotropium; tiotropium + olodaterol; Placebo; Respimat
Intervention description: low dose + one dose only; low dose; one dose only; high dose; low dose + one dose only; placebo matching tiotropium+olodaterol FDC; Respimat inhaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 219.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of the trial is to determine the 24-hour FEV1-time profile of
      tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of chronic obstructive pulmonary disease

          2. Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted
             normal and a post-bronchodilator FEV1/FVC <70%

          3. Male or female patients, 40 years of age or older

          4. Smoking history of more than 10 pack years

          5. Ability to perform technically acceptable pulmonary function tests and maintain
             records

          6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from
             a metered dose inhaler (MDI)

        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

          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. history of thoracotomy with pulmonary resection

         16. oral or patch ß-adrenergics

         17. oral corticosteroid medication at unstable doses

         18. regular use 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, BAC, EDTA

         22. Pregnant or nursing women

         23. Women of childbearing potential not using a highly effective method of birth control

         24. Patients who have previously been randomised in this study or are currently
             participating in another study

         25. Patients who are unable to comply with pulmonary medication restrictions prior to
             randomisation