A Study to Test the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler in People With Chronic Obstructive Pulmonary Disease (COPD) Who Have Different Abilities to Inhale
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium + olodaterol; Placebo
Intervention description: Oral Inhalation; Oral Inhalation
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To demonstrate the efficacy of inhaled tiotropium + olodaterol via Respimat® on lung function
      in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with optimal
      and sub-optimal Peak Inspiratory Flow Rate (PIFR). Disease severity (moderate to severe) is
      based on the Global Initiative for Chronic Lung Disease (GOLD) guidelines (GOLD 2 - 3)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated written informed consent in accordance with International Council on
             Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to
             admission to the trial.

          -  Male or female patients, 40 years of age or older.

          -  All patients must have a diagnosis of chronic obstructive pulmonary disease and must
             meet the following spirometric criteria: patients with a post-bronchodilator Forced
             Expiratory Volume in one second (FEV1) >30% and <80% of predicted normal (European
             Coal and Steel Community (ECSC), [R94-1408]); and a postbronchodilator FEV1/
             Functional Residual Capacity (FVC) <70%, at the screening visit.

          -  Patients must be current or ex-smokers with a smoking history of more than 10 pack
             years

          -  Patients should meet the peak inspiratory flow rate criteria (optimal or sub-optimal)
             at the time of randomization depending on which strata is available for inclusion in
             the study.

          -  Women of childbearing potential must be ready and able to use highly effective methods
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
             year when used consistently and correctly. A list of contraception methods meeting
             these criteria is provided in the patient information.

          -  Patients are expected to be able to perform, according to investigator's judgment, all
             trial related procedures including:

               -  Technically acceptable pulmonary function tests (spirometry)

               -  Use of In-Check DIAL G16 device to measure peak inspiratory flow rate.

               -  Inhale medication in a competent manner (in the opinion of the investigator) from
                  the Respimat® device

               -  Perform technically acceptable body plethysmography measurements. This is
                  applicable only to patients who will consent to the optional trial procedure at
                  the selected sites.

        Exclusion Criteria:

          -  Patients with a significant disease other than chronic obstructive pulmonary disease;
             a significant disease defined as a disease which, in the opinion of the investigator,
             and referring to the warnings to be observed as quoted in the locally applicable SmPC
             or prescribing information, could (i) put the patient at risk because of participation
             in the trial, (ii) influence the results of the trial, or (iii) cause concern
             regarding the patient's ability to participate in the trial.

          -  Patients who have had a chronic obstructive pulmonary disease exacerbation that
             required treatment with antibiotics, systemic steroids (oral or intravenous) or
             hospitalization in the 6 weeks prior to screening visit or during the screening
             period.

          -  Patients who experienced two or more moderate chronic obstructive pulmonary disease
             exacerbations (exacerbation that required treatment with antibiotics and/or oral
             corticosteroids), or one or more exacerbation leading to hospitalization within a year
             prior to visit 1.

          -  Patients with a history of asthma. For patients with allergic rhinitis or atopy,
             source documentation is required to verify that the patient does not have asthma.

          -  Patients taking inhaled corticosteroids (including combinations, e.g. inhaled
             corticosteroids / Long-Acting β2-agonist) in the 6 months prior to screening visit.

          -  Patients being treated with oral corticosteroid medication due to reasons other than
             chronic obstructive pulmonary disease exacerbation within 6 weeks prior to the
             screening visit.

          -  Patients who have completed a pulmonary rehabilitation program in the 6 weeks prior to
             screening visit or patients who are currently in a pulmonary rehabilitation program.

          -  Further criteria apply