Value through Innovation27 July 2016

Clinical Study Results

  • SPIOLTO ® - Healthy
    Clinical Study Number 1237.1
    Study Indication Healthy
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising inhaled doses (2.5 µg, 5 µg, 10 µg, 20 µg and 40 µg) of BI 1744 CL (administered with the Respimat®) in free dose combination with tiotropium bromide 5 µg ( for doses up to and including 20 µg BI 1744 CL), 10 µg (for doses of 20 µg and 40 µg BI 1744 CL) (administered with the Respimat®) in healthy male volunteers

    Study Document Trial synopsis 1237.1 english
  • SPIOLTO ® - Healthy
    Clinical Study Number 1237.2
    Study Indication Healthy
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising inhalative doses (2mcg/5mcg, 10mcg/5mcg and 40mcg/10mcg) of BI 1744 CL in fixed dose combination with Tiotropium Bromide for 14 days in healthy male volunteers (double-blind, randomised, placebo controlled [at each dose level] study)

    Study Document Trial synopsis 1237.2 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, 3-way crossover study to compare pharmacokinetics and safety of 10 mcg BI 1744 CL plus 5 mcg tiotropium bromide given as fixed dose combination via the Respimat Inhaler with the pharmacokinetics and the safety of the single agents, i.e., 10 mcg BI 1744 CL and 5 mcg tiotropium bromide, delivered via the Respimat Inhaler, following 21-day treatment periods in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1237.3 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIa
    Study Title

    A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1].  Combined analysis of efficacy data obtained in the replicate studies 1237.5 and 1237.6

    Study Document Trial synopsis 1237.5_DR english Combined analysis of 1237.5 and 1237.6_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.6
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the Respimat® Inhaler) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the Respimat® Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2].  Combined analysis of efficacy data obtained in the replicate studies 1237.5 and 1237.6

    Study Document Trial synopsis 1237.6_DR english Combined analysis of 1237.5 and 1237.6_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.9
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, double-blind, cross-over study to assess the efficacy and safety of   4 weeks of once daily treatment of 2 doses of orally inhaled BI 1744 CL, each in fixed dose combination (FDC) with 5 µg tiotropium bromide (delivered by the respimat® inhaler) in patients with COPD

    Study Document Trial synopsis 1237.9_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, each in fixed dose combination with 5 µg Tiotropium Bromide (Delivered by the Respimat® Inhaler) compared with 5µg Tiotropium Bromide Monoproduct (Delivered by the Respimat® Inhaler) in Patients with COPD

    Study Document Trial synopsis 1237.4_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.18
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study to determine the optimal free dose combination of olodaterol and tiotropium (both delivered by the Respimat® Inhaler) after 4 weeks once daily treatment in patients with COPD

    Study Document Trial synopsis 1237.18_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.24
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomised, open-label, parallel-group trial to assess pharmacokinetics and safety of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.24 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.13
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ), and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) [MORACTO™ 1]

    Study Document Trial synopsis 1237.13_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ), and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) [MORACTO™ 2]

    Study Document Trial synopsis 1237.14_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.15
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled, parallel group study to determine the effect of 12 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg) delivered by the Respimat® Inhaler, on exercise endurance time during constant work rate cycle ergometry inpatients with Chronic Obstructive Pulmonary Disease (COPD) [TorractoTM]

    Study Document Trial synopsis 1237.15_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.20
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg), tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]

    Study Document Trial synopsis 1237.20_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.22
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, parallel-group study to assess the safety and efficacy of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) and olodaterol (5 µg) delivered by the Respimat® inhaler in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.22_DS_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.7
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, placebo-controlled, double-blind, single dose, cross-over trial to evaluate the efficacy and safety of orally inhaled tiotropium + olodaterol as both a fixed dose combination and a free combination (both delivered by the RESPIMAT® inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.7_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.25
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [OTEMTO™1]

    Study Document Trial synopsis 1237.25_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.26
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat® inhaler) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) [OTEMTO™2]

    Study Document Trial synopsis 1237.26_DR english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.11
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat® inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler® in patients with Chronic Obstructive Pulmonary Disease (COPD

    Study Document Trial synopsis 1237.11_DR english
  • 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 Trial synopsis 1237.16_CO english Lay summary 1237.16 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.49
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium+olodaterol fixed-dose combination (5/5 μg) delivered by the RESPIMAT® inhaler versus the free combination of tiotropium 5 μg and olodaterol 5 μg delivered by separate RESPIMAT® inhalers in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.49 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.42
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol , Tramazoline
    Lab Code
    Clinical Phase IV
    Study Title

    SPIRIT: Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice

    Study Document Trial synopsis 1237.42 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.33
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blinded, active-controlled 2-way crossover trial to assess the effects of 6 weeks once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination delivered by RESPIMAT Inhaler compared with tiotropium delivered by RESPIMAT Inhaler on lung hyperinflation, exercise capacity, and physical activity in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.33 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.19
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed-dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD. [DYNAGITO]

    Study Document Trial synopsis 1237.19 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.44
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice

    Study Document Trial synopsis 1237.44 english
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.30
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase Ib
    Study Title

    An open-label trial to assess pharmacokinetics and safety of tiotropium + olodaterol fixed-dose combination (5 μg/ 5 μg) delivered by the RESPIMAT® inhaler after single and multiple dose treatment in Chinese patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1237.30 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 Trial synopsis 1237.28 english Lay summary 1237.28 english Lay summary 1237.28 dutch Lay summary 1237.28 french Lay summary 1237.28 german
  • SPIOLTO ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1237.51
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product SPIOLTO ®
    Generic Name Tiotropium bromide + Olodaterol
    Lab Code
    Clinical Phase IV
    Study Title

    SATisfaction and adherence to COPD treatment

    Study Document Trial synopsis 1237.51 english

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