Value through Innovation27 July 2016

Clinical Study Results

  • BEA 2180 - Healthy
    Clinical Study Number 1205.1
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacodynamics and pharmacokinetics of single rising inhaled BEA 2180 BR doses (2.5 µg to 1600 µg administered with the Respimat®) in healthy male subjects, alone and followed by methacholine challenge. A randomised, double-blind within dose group, placebo-controlled study, with a 36 µg tiotropium bromide single dose sub-study (open, two-fold crossover).

    Study Document Trial synopsis 1205.1_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.2
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising inhalative doses (20 µg, 50 µg, 100 µg, 200 µg, and 400 µg) of BEA 2180 BR for 21 days in healthy male volunteers (double-blind, randomised, placebo controlled [at each dose level] study)

    Study Document Trial synopsis 1205.2_CO english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.3
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIa
    Study Title

    Randomised, Double-Blind, Placebo-Controlled, 4-Way Cross-Over Study to Assess the Efficacy and Safety of a Single Dose of Orally Inhaled BEA 2180 BR (doses 80, 200 and 800 µg) in COPD Patients Followed by an Open-Label, Active-Control (tiotropium 72 µg)

    Study Document Trial synopsis 1205.3_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.5
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising intravenous doses (2.5 µg, 7.5 µg, 25 µg, 50 µg, 100 µg, 200 µg, 350 µg, 500 µg free cation) BEA 2180 BR in healthy male volunteers with an additional arm by inhalation in one dose group (1600 µg)

    Study Document Trial synopsis 1205.5 english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.8
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    Investigation of the metabolism and pharmacokinetics of 1200 µg (free cation)[14C] BEA 2180 BR administered orally compared to 500 µg (free cation) [14C] BEA 2180 BR administered intravenously in healthy male volunteers in an open label, single-dose and parallel study design

    Study Document Trial synopsis 1205.8_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.18
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability and pharmacokinetics of multiple rising inhalative doses (50 µg, 100 µg and 200 µg q.d. for 14 days) of BEA 2180 BR in Japanese healthy male volunteers

    Study Document Trial synopsis 1205.18_CO english
  • BEA 2180 - Healthy
    Clinical Study Number 1205.20
    Study Indication Healthy
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, single-blind, placebo-controlled (within dose groups) study to assess safety, tolerability and pharmacokinetics of single rising peroral doses (400, 800, 1200 µg free cation) BEA 2180 BR in healthy male volunteers.

    Study Document Trial synopsis 1205.20_CO english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.14
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A multinational, randomized, double-blind, placebo- and active-controlled, parallel group efficacy and safety comparison over 24 weeks of three doses (50 µg , 100 µg, 200 µg) of BEA 2180 to tiotropium 5 µg and placebo deliveredby the Respimat® inhaler in patients with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1205.14_DR english Pooled analysis 1205.14_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomized, multiple-dose, double-blind, placebo- and active controlled, parallel group efficacy and safety study to determine the optimum dose of BEA 2180 BR delivered by the Respimat® inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1205.4_DR english
  • BEA 2180 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1205.6
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BEA 2180
    Generic Name BEA 2180
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 µg and 400 µg of BEA 2180 BR to Tiotropium 5 µg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 1205.6_DR english

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