Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: olodaterol; tiotropium; Placebo; tiotropium; olodaterol
Intervention description: free combination with tiotropium; free combination with olodaterol; fixed dose combination with olodaterol; fixed dose combination with tiotropium
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 53.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy and safety of orally inhaled
      tiotropium and olodaterol as both a fixed dose combination and a free combination with
      respect to lung function and ECG parameters
    

Eligibility criteria:

        Inclusion criteria:

          -  patients must sign informed consent consistent with ICH-GCP guidelines prior to
             participation in the trial, which includes medication washout and restrictions.

          -  Patients must have a diagnosis of COPD and must meet the following spirometric
             criteria:

        Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to
        45 minutes after 400mcg salbutamol) FEV1>30% and < 80% of predicted normal (ECSC, GOLD II -
        III) and a post-bronchodilator FEV1/FVC <70% at Visit 1

          -  Male or female patients, 40 years of age or older.

          -  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 must be able to perform technically acceptable pulmonary function tests
             according to ATS/ERS guidelines and maintain records in a paper diary

          -  Patients must be able to inhale medication in a competent manner from the RESPIMAT
             inhaler and from a metered dose inhaler (MDI).

        Exclusion criteria:

          -  Significant disease other than COPD

          -  Clinically relevant abnormal lab values.

          -  History of asthma.

          -  Diagnosis of thyrotoxicosis

          -  Diagnosis of paroxysmal tachycardia

          -  History of myocardial infarction within 1 year of screening visit

          -  Unstable or life-threatening cardiac arrhythmia

          -  Hospitalization for heart failure within the past year

          -  Known active tuberculosis

          -  Malignancy for which patient has undergone resection, radiation therapy or
             chemotherapy within last five years

          -  History of life-threatening pulmonary obstruction and patients with chronic
             respiratory failure

          -  History of cystic fibrosis

          -  Clinically evident bronchiectasis

          -  History of significant alcohol or drug abuse

          -  Thoracotomy with pulmonary resection

          -  Patients treated with oral or patch ß-adrenergics

          -  Patients treated with oral corticosteroid medication at unstable doses or at doses in
             excess of 10mg prednisolone per day or equivalent

          -  Regular use of daytime oxygen therapy for more than one hour per day

          -  Pulmonary rehabilitation program in the six weeks prior to the screening visit or
             patients currently in a pulmonary rehabilitation program

          -  Investigational drug within one month or six half lives (whichever is greater) prior
             to screening visit

          -  Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA

          -  Pregnant or nursing women

          -  Women of childbearing potential not using a highly effective method of birth control

          -  Patient who have previously been randomized in this study or are currently
             participating in another study

          -  Patients who are unable to comply with pulmonary medication restrictions prior to
             randomization