Value through Innovation27 July 2016

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Clinical Study Results

  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1365
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD) with poor MDI technique.

    Study Document
    Trial synopsis 215.1365_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1364
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngeal deposition with the Respimat® inhaler vs. a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary disease (COPD).

    Study Document
    Trial synopsis 215.1364 english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1104
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    Comparison of the safety and efficacy of Berodual® administered via Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10 mcg ipratropium bromide, 1 puff q.i.d.) with that administered via the MDI (50 mcg fenoterol hydrobromide/21 mcg ipratropium bromide, 2 puffs q.i.d.) in asthma patients over a 12-week period.

    Study Document
    Trial synopsis 215.1104 english
  • BERODUAL ® - Asthma
    Clinical Study Number 215.1105
    Study Indication Asthma
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind study to compare the safety and efficacy of Berodual® inhaled via the Respimat® device in two dosages (50 µg fenoterol hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium bromide, 1 puff t.i.d) with that of Berodual® inhaled via the Chlorofluorocarbons (CFC)-metered dose inhaler (MDI) with Aerochamber® (50 µg fenoterol hydrobromide + 21 µg ipratropium bromide, 2 puffs t.i.d.) in paediatric patients with asthma over a 4 week period

    Study Document
    Trial synopsis 215.1105 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1349
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, placebo-controlled, within-device, double-blind tri-national study to compare the safety and efficacy of Berodual® administered via the Respimat® device (50 mcg fenoterol hydrobromide/20 mcg ipratropium bromide and 25 mcg fenoterol hydrobromide/10mcg ipratropium bromide, 1 puff q.i.d.) with that administered via the MDI (50 mcg fenoterol hydrobromide/21 mcg ipratropium bromide, 2 puffs q.i.d..) in COPD patients over a 12-week period.

    Study Document
    Trial synopsis 215.1349 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1352
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Postrnarketing surveillance study (as per§ 67 (6) AMG [German DrugLaw]) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1352 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1353
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with§ 67,6 AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1353 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1357
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Berodual® Respimat® Inhaler (20g ipratropium bromide/50g fenoterol hydrobromide, 1 actuation t.i.d./q.i.d.) versus Berodual® MA using HFA 134a as propellant (20g ipratropium bromide (anhydrous)/50g fenoterol hydrobromide, 2 puffs t.i.d./q.i.d.) in adult patients with asthma, chronic obstructive pulmonary disease, or mixed conditions, an open-label, crossover trial over a 7-week treatment period with each formulation:"A Study To Compare Patient Preference"

    Study Document
    Trial synopsis 215.1357_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1358
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease

    Study Document
    Trial synopsis 215.1358 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1360
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, four way, cross-over scintigraphic evaluation of the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic Obstructive Pulmonary Disease(COPD) with poor MDI technique

    Study Document
    Trial synopsis 215.1360_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1361
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngealde position with the Respimat® inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodual® in patients with Chronic ObstructivePulmonary Disease (COPD)

    Study Document
    Trial synopsis 215.1361_CO english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1362
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document
    Trial synopsis 215.1362 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1363
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease

    Study Document
    Trial synopsis 215.1363 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1366
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction in comparison to a powder inhaler

    Study Document
    Trial synopsis 215.1366 english
  • BERODUAL ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 215.1367
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product BERODUAL ®
    Generic Name Ipratropium bromide + Fenoterol
    Lab Code
    Clinical Phase IV
    Study Title

    Berodual® Respimat® 20/50 mcg/dose solution for inhalation: Assessment of handling and patient satifaction

    Study Document
    Trial synopsis 215.1367 english