Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone propionate; salmeterol; placebo; placebo; tiotropium; olodaterol; olodaterol; placebo; placebo; tiotropium; fluticasone propionate; salmeterol
Intervention description: low dose; placebo/dummy for blinding purposes; placebo/dummy for blinding purposes; tiotropium high dose; placebo/dummy for blinding purposes; placebo/dummy for blinding purposes; tiotropium low dose; low dose
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide; Salmeterol Xinafoate; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 229.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to compare the lung function profile of once daily treatment
      with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung
      function profile of twice daily treatment with fluticasone propionate+salmeterol FDC
      [250/50µg and 500/50µg] delivered by the Accuhaler® 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 30% </= Forced
             Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator
             FEV1/(Forced Vital Capacity)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,
             Accuhaler and from a metered dose inhaler (MDI)

        Exclusion criteria:

          1. Significant disease other than COPD

          2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or
             iv) or hospitalization in the last 3 months.

          3. Clinically relevant abnormal lab values

          4. History of asthma

          5. Diagnosis of thyrotoxicosis

          6. Diagnosis of paroxysmal tachycardia

          7. History of myocardial infarction

          8. Unstable or life-threatening cardiac arrhythmia

          9. Hospitalization for heart failure within the past year

         10. Known active tuberculosis

         11. malignancy for which patient has undergone resection, radiation therapy or
             chemotherapy within last five years

         12. History of life-threatening pulmonary obstruction

         13. History of cystic fibrosis

         14. Clinically evident bronchiectasis

         15. History of significant alcohol or drug abuse

         16. History of thoracotomy with pulmonary resection

         17. oral or patch ß-adrenergics

         18. Oral corticosteroid medication within 6 weeks prior to Visit 1

         19. Regular use daytime oxygen therapy for more than one hour per day

         20. Pulmonary rehabilitation program in the six weeks prior to the screening visit

         21. Investigational drug within one month or six half lives (whichever is greater) prior
             to screening visit

         22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA

         23. Pregnant or nursing women