Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide/formoterol (Symbicort® Turbuhaler®); Tiotropium (SpirivaTM)
Intervention description: Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily; Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Tiotropium Bromide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 793.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients

Summary:

      This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV
      design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva
      compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease
      (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Men or women patients ≥40 years of age

          -  Diagnosis of COPD with symptoms for more than 2 years and there is a history of at
             least one COPD exacerbation requiring a course of oral steroids and/or antibiotics
             within 1-12 months before Visit 2

          -  Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value,
             pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital
             Capacity (FVC) < 70%, pre-bronchodilator

          -  Total symptom score of 2 or more per day for at least half of run-in period
             (breathing, cough and sputum scores from the diary card) and complete morning
             recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the
             run-in period

        Exclusion Criteria:

          -  A history of asthma and seasonal allergic rhinitis before 40 years of age

          -  Patients who have experienced exacerbation of COPD requiring hospitalisation and /or
             emergency room treatment and/or a course of oral steroids and/or intravenous
             corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during
             run-in period and also the patients who use of systemic glucocorticosteroids (GCS)
             within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in
             period

          -  Patients with relevant cardiovascular disorder judged by the investigator

          -  Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by
             the investigator

          -  Women who are pregnant, breast-feeding or of child-bearing potential judged by the
             investigator