Value through Innovation27 July 2016

Clinical Study Results

  • BI 54903 - Asthma
    Clinical Study Number 1248.5
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 22.7, 45.5 and 90.9 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 88 µg b.i.d. in patients with asthma inadequately controlled on SABA therapy

    Study Document Trial statement 1248.5_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.6
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 µg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy

    Study Document Trial statement 1248.6_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1248.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIb
    Study Title

    A randomised, double-blind, double-dummy, active-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 90.9, 181.8 and 363.6 µg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 440 µg b.i.d. in patients with asthma inadequately controlled on medium dose ICS therapy

    Study Document Trial statement 1248.7_DR english Trial synopsis 1248.5_6_7_DR english
  • BI 54903 - Asthma
    Clinical Study Number 1249.7
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase IIa
    Study Title

    A single dose, placebo-controlled, randomised, double-blind double dummy, 5-way crossover (7 treatments, 5 periods incomplete block), including 24-h pulmonary function tests, pharmacodynamic comparison of olodaterol/BI 54903 fixed dose combination inhalation solutions via Respimat® (including clinical doses of 1.23/363.6 µg, 2.46/363.6 µg and 4.93/363.6 µg) versus free combinations of olodaterol inhalation solutions (0, 2.5µg, 5 µg and 10 µg) via Respimat® plus BI 54903 inhalation solution (363.6 µg ) in patients with asthma.

    Study Document Trial statement 1249.7_DR english
  • BI 54903 - Healthy
    Clinical Study Number 1256.1
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising inhalative doses (delivered doses of 23 to 69 µg q.d. and 69 µg b.i.d. for four days) of butylated hydroxytoluene (an excipient novel for inhalation administration) via Respimat® Soft Mist TM Inhaler B (randomised,double-blind, placebo-controlled sub-study 1) and safety, tolerability and pharmacokinetics of multiple rising inhalative doses (fine particle doses of 160 to 1280 µg q.d. for 10 days) of BI 54903 XX via Respimat® Soft Mist TM Inhaler B as randomised, double-blind, placebo-controlled Phase I trial in healthy male volunteers (main study) and comparison of systemic exposure following a single fine particle dose of 640 µg BI 54903 XX via Respimat® Soft Mist TM Inhaler B and of a single fine particle dose of 640 µg Alvesco® (ciclesonide) via MDI (randomised,open-label, two-way crossover sub-study 2)

    Study Document Trial synopsis 1256.1 english
  • BI 54903 - Asthma
    Clinical Study Number 1256.13
    Study Indication Asthma
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase Ib
    Study Title

    Serial lung function measurements in 12 healthy and 48 mild asthmatic adults after oral inhalation of ethanolic solutions containing two concentrations of the excipient butylated hydroxytoluene (BHT, 0.1% and 0.5%) administered with the Respimat® B (RMT-B) vs. corresponding RMT-B and HFA MDI without BHT; repeated increasing doses with 2, 4, and 6 actuations of low concentration prior to high concentration on separate days, double blind for RMT-B use, randomised 4-way cross-over design

    Study Document Trial synopsis 1256.13_CO english
  • BI 54903 - Healthy
    Clinical Study Number 1256.2
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    A single-blind, randomised, two-way crossover Phase I study to assess safety, tolerability and pharmacokinetics of the fixed dose combination of BI 1744 CL plus BI 54903 XX via Respimat® B versus the free combination of BI 1744 CL via Respimat® A and BI 54903 XX via Respimat® B in healthy male and female volunteers

    Study Document Trial synopsis 1256.2 english
  • BI 54903 - Healthy
    Clinical Study Number 1256.3
    Study Indication Healthy
    Product BI 54903
    Generic Name BI 54903
    Lab Code
    Clinical Phase I
    Study Title

    An open label, randomised, three-way cross over Phase I study to assess safety, tolerability and pharmacokinetics of the fixed dose combination of BI 1744 CL plus BI 54903 XX via Respimat® B versus the mono products of BI 1744 CL via Respimat® A and BI 54903 XX via Respimat® B in healthy male and female volunteers

    Study Document Trial synopsis 1256.3 english

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