Value through Innovation27 July 2016

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Clinical Study Results

  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.36
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses of BIIL 284 BS in adult and pediatric cystic fibrosis patients

    Study Document
    Trial synopsis 543.36_CO english
  • Amelubant - Cystic Fibrosis
    Clinical Study Number 543.37
    Study Indication Cystic Fibrosis
    Product Amelubant
    Generic Name Amelubant
    Lab Code
    Clinical Phase Ib
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of repeated oral doses (15-day dosing) of BIIL 284 BS in adult (150 mg) and pediatric (75 mg) cystic fibrosis patients 

    Study Document
    Trial synopsis 543.37 english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.338
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase I
    Study Title

    A randomized, double-blind within dose, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of increasing single and multiple doses (28-day dosing) of tiotropium bromide administered once daily via the Respimat® device in cystic fibrosis patients

    Study Document
    Trial synopsis 205.338_CO english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.339
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A randomised, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat® device for 12 weeks in patients with cystic fibrosis

    Study Document
    Trial synopsis 205.339_DS_CO english
  • SPIRIVA ® - Cystic Fibrosis
    Clinical Study Number 205.438
    Study Indication Cystic Fibrosis
    Product SPIRIVA ®
    Generic Name Tiotropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis

    Study Document
    Trial synopsis 205.438_DS_CO english
  • BI 443651 - Cystic Fibrosis , Healthy
    Clinical Study Number 1363.2
    Study Indication Cystic Fibrosis ; Healthy
    Product BI 443651
    Generic Name BI 443651
    Lab Code BI 443651
    Clinical Phase Ib
    Study Title

    A Phase Ib, multicentre, double blind, randomised, two-part study, first part multiple rising dose and second part two-way cross-over, to assess safety, tolerability, efficacy and pharmacokinetics of BI 443651 compared to placebo via Respimat® in healthy volunteers and cystic fibrosis subjects

    Study Document
    Trial synopsis 1363.2 english
    Lay summary 1363.2 english
    Lay summary 1363.2 german