Value through Innovation27 July 2016

Clinical Study Results

  • BIBW 2948 - Healthy
    Clinical Study Number 1219.1
    Study Indication Healthy
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, double-blind, placebo-controlled (within dose groups) study to evaluate safety, tolerability and pharmacokinetics of single rising inhaled doses BIBW 2948 BS (0.75 to 150 mg inhalation powder, hard capsule for HandiHaler®) in healthy male volunteers.

    Study Document Trial synopsis 1219.1 english
  • BIBW 2948 - Healthy
    Clinical Study Number 1219.3
    Study Indication Healthy
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of multiple rising inhaled doses (7.5 to 60 mg daily for 12 days) of BIBW 2948 BS inhalation powder, hard capsule for HandiHaler® in healthy male volunteers (randomised, double-blind placebo-controlled within dose groups)

    Study Document Trial synopsis 1219.3 english
  • BIBW 2948 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1219.5
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase IIa
    Study Title

    A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 15 and 30 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis

    Study Document Trial synopsis 1219.5 english
  • BIBW 2948 - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1219.4
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BIBW 2948
    Generic Name BIBW 2948
    Lab Code
    Clinical Phase IIa
    Study Title

    A phase II, randomised, double-blind, placebo-controlled and parallel group study to evaluate the safety and efficacy of four weeks treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) in patients with COPD associated with chronic bronchitis.

    Study Document Trial statement 1219.4_DR english

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