Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: olodaterol; tiotropium; 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: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7903.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed
      dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on
      moderate to severe COPD exacerbation in patients with severe to very severe COPD.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients, 40 years of age or older.

          -  Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in
             one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced
             vital capacity (FVC) <70% at Visit 1

          -  Documented history of at least one moderate to severe COPD exacerbation in the
             previous 12 months requiring treatment with systemic corticosteroids and/or
             antibiotics and/or related hospitalization.

          -  Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use
             of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of
             change in their usual COPD medication 4 weeks prior to visit 1.

          -  Current or ex-smokers with a smoking history of more than 10 pack years.

        Exclusion criteria:

          -  Significant disease other than COPD.

          -  Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2
             ULN will be excluded regardless of clinical condition. ( A repeat laboratory
             evaluation can be conducted if deemed necessary by the investigator.)

          -  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

          -  A diagnosis of thyrotoxicosis

          -  A history of myocardial infarction within 6 months of screening visit.

          -  Life-threatening cardiac arrhythmia.

          -  Known active tuberculosis.

          -  Any malignancy unless free of disease for at least 5 years (patients with treated
             basal cell carcinoma or squamous cell skin cancers are allowed).

          -  A history of cystic fibrosis.

          -  Clinically relevant bronchiectasis.

          -  Patients with severe emphysema requiring endobronchial interventions within 6 months
             prior to screening

          -  A history of significant alcohol or drug abuse in the opinion of the investigator.

          -  Patients who have undergone thoracotomy with pulmonary resection

          -  Patients being treated with oral or patch ß-adrenergics.

          -  Patients being treated with oral corticosteroid medication at unstable doses

          -  Patients being treated with antibiotics for any reasons within 4 weeks of screening
             visit

          -  Patients being treated with PDE4 inhibitors within 3 months of screening visit

          -  Patients who have taken an investigational drug within one month or six half-lives

          -  Pregnant or nursing women.

          -  Women of childbearing potential not using a highly effective method of birth control.