Value through Innovation27 July 2016

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Clinical Study Results

  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.10
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (25 µg salmeterol), administered as the xinafoate salt from a hard polyethylene capsule via the HandiHaler® 2, and Serevent® Diskus® (50 µg salmeterol) in patients with chronic obstructive pulmonary disease (COPD)

    Study Document
    Trial synopsis 1184.10_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.12
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiortopium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (12.5 µg, 25 µg and 50 µg salmeterol), administered as the xinafoate salt from hard polyethylene capsules via the HandiHaler® 2, and Serevent® Diskus® (50 µg salmeterol) in patients with chronic obstructive pulmonary disease (COPD)

    Study Document
    Trial synopsis 1184.12 english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.13
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, crossover efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/25 µg) Inhalation Powder in the morning (PE Capsule via tiotropium/salmeterol HandiHaler®), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®), Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening and the free combination Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®) plus Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening following chronic administration (6-week treatment periods) in patients with COPD

    Study Document
    Trial synopsis 1184.13_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week (+ 24 week extension) placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol plus Salmeterol in COPD patients

    Study Document
    Trial synopsis 1184.14 english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.15
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A 24-week (+ 24 week extension) placebo-controlled (only 1st 12-week period), double–blind, parallel-group, efficacy and safety comparison of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol plus Salmeterol in COPD patients

    Study Document
    Trial synopsis 1184.15 english
  • Tiotropium bromide + Salmeterol - Healthy
    Clinical Study Number 1184.17
    Study Indication Healthy
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, open-label three-way crossover study to evaluate the pharmacokinetics of salmeterol after inhalation of a 25 µg and 50 µg single dose (inhalation powder, hard PE capsule for HandiHaler®2) and a 50 µg single dose (Serevent® Diskus®) in healthy male volunteers

    Study Document
    Trial synopsis 1184.17_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.9
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase II
    Study Title

    A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of tiotropium inhalation powder (5 µg and 10 µg), administered as the bromide salt from hardpolyethylene capsule via the HandiHaler® 2, and Spiriva® HandiHaler® (18 µg tiotropium) in patients with chronic obstructive pulmonary disease (COPD).

    Study Document
    Trial synopsis 1184.9_DR english
  • Tiotropium bromide + Salmeterol - Healthy
    Clinical Study Number 1184.11
    Study Indication Healthy
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, open-label four-way crossover study to evaluate relative bioavailability of tiotropium and salmeterol after inhalation of a fixed combined single dose (7.5 µg tiotropium, 25 µg salmeterol, inhalation powder, hardcapsule, HandiHaler®2), a free combined single dose of 18 µg tiotropium[Spiriva® HandiHaler®] and 50 µg salmeterol [Serevent® Diskus®], a single dose of 50 µg salmeterol (Serevent® Diskus®) and a single dose of 18 µg tiotropium (Spiriva® HandiHaler®) in healthy male volunteers

    Study Document
    Trial synopsis 1184.11_DR english
  • Tiotropium bromide + Salmeterol - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1184.24
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product Tiotropium bromide + Salmeterol
    Generic Name Tiotropium bromide + Salmeterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, open-label, 4-way crossover study to characterize the pharmacokinetics, safety and efficacy of FDC Tiotropium/Salmeterol,Tiotropium, Salmeterol and a free combination of Tiotropium plus Salmeterol following 4-week treatment periods in patients with COPD.

    Study Document
    Trial synopsis 1184.24 english