Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; olodaterol; tiotropium
Intervention description: fixed dose combination; fixed dose combination
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial
      to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol
      FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung
      hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6
      weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion criteria:

          -  All patients must sign an informed consent consistent with International Conference on
             Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in
             the trial, which includes medication washout and restrictions.

          -  All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and
             must meet the following spirometric criteria:

        Patients must have relatively stable airway obstruction with a post-bronchodilator Forced
        expiratory volume in one second (FEV1) < 80% of predicted normal and post-bronchodilator
        FEV1/forced vital capacity (FVC) < 70% at Visit 1.

          -  Male or female patients, aged >= 40 years.

          -  Patients must be current or ex-smokers with a smoking history of more than 10 pack
             years. Patients who have never smoked cigarettes must be excluded.

          -  Patients with score on the modified Medical Research Council (mMRC) >= 1.

          -  Patients who walk < 400 meters of 6MWT and have a score on the modified Borg >= 4 at
             the end of 6 minute walk test (6MWT) at Visit 2.

          -  Patients must be able to perform technically acceptable pulmonary function tests
             (spirometry), to use the physical activity monitor and must be able to complete 6MWT
             during the study period as required in the protocol.

          -  Patients must be able to inhale medication in a competent manner from the RESPIMAT
             Inhaler and from a metered dose inhaler.

        Exclusion criteria:

          -  Patients with a significant disease other than COPD; a significant disease is defined
             as a disease which, in the opinion of the investigator, may put the patient at risk
             because of participation in the study, influence the results of the study and cause
             concern regarding the patient's ability to participate in the study.

          -  Patients with clinically relevant abnormal baseline haematology, blood
             chemistry,urinalysis or creatinine > x2 upper limit of normal (ULN) will be excluded
             regardless of clinical condition (a repeat laboratory evaluation can be conducted if
             deemed necessary by the investigator).

          -  Patients with a current documented diagnosis of asthma. For patients with allergic
             rhinitis or atopy, source documentation is required to verify that the patient does
             not have asthma.

          -  Further exclusion criteria apply