Value through Innovation27 July 2016

Clinical Study Results

  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.16
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    An exploratory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Lay summary 1237.16 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.28
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 μg) compared with tiotropium (5 μg), both delivered by the Respimat® Inhaler, on breathlessness during the three minute Constant Speed Shuttle Test (3min CSST) in patients with Chronic Obstructive Pulmonary Disease (COPD) [OTIVATOTM]

    Study Document Lay summary 1237.28 english Lay summary 1237.28 dutch Lay summary 1237.28 french Lay summary 1237.28 german

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