Value through Innovation27 July 2016

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

Clinical Trial Registry and structured study results. Find here protocol information for all clinical study types.

European Trial Register of EU studies.