Value through Innovation27 July 2016

Clinical Study Results

  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.46
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A comparison of ipratropium bromide/salbutamol delivered by the Respimat® inhaler to ipratropium bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo of each formulation in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease.

    Study Document Trial Supplement and Synopsis 1012.46_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.50
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    A single dose randomized, double-blind crossover comparison of COMBIVENT® CFC MDI and albuterol HFA MDI in patients with moderate to severe persistent asthma and persistent symptoms despite treatment with inhaled corticosteroids

    Study Document Trial synopsis 1012.50_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.56
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A comparison of ipratropium bromide/salbutamol delivered by the Respimat® inhaler to Combivent® Inhalation Aerosol and ipratropium bromide delivered by the Respimat® in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease

    Study Document Trial synopsis 1012.56 english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.57
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase II
    Study Title

    A multicenter, randomized study starting with a 4-week, 2-way crossover double-blind treatment phase comparing the efficacy and safety of Combivent® CFC MDI to albuterol HFA MDI followed by a 4-week open-label Combivent® Respimat® treatment phase when all study drugs are used for symptom relief “as needed” in patients with moderate-to-severe asthma (GINA 2007 Treatment Steps 3-5)

    Study Document Trial synopsis 1012.57_DS_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.62
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIIb
    Study Title

    Phase III, one-year, randomized, open-label safety and patient acceptability study of Combivent® Respimat® (ipratropium bromide and albuterol sulfate) (20/100 mcg) Inhalation Spray in comparison to Combivent® Inhalation Aerosol  (36/206 mcg) and the free combination of Atrovent® HFA (ipratropium bromide  HFA) inhalation Aerosol (34 mcg) and albuterol HFA inhalation aerosol (180 mcg) in adults with chronic obstructive pulmonary disease (COPD)

    Study Document Trial synopsis 1012.62_DS_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.11
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    A one-year randomized, double-blind, placebo and active-controlled parallel design safety and efficacy comparison of COMBIVENT HFA Inhalation Aerosol to COMBIVENT® (CFC) Inhalation Aerosol in patients with COPD

    Study Document Trial synopsis 1012.11 english
  • COMBIVENT ® - Healthy
    Clinical Study Number 1012.24
    Study Indication Healthy
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase I
    Study Title

    A randomised, placebo-controlled, double-blind, 3 way cross-over safety and tolerability study of single and repetitive dosing of COMBIVENT HFA compared to COMBIVENT® CFC and placebo HFA in healthy male and female subjects (cumulative dose: 1600 mcg (HFA) or 1648 mcg (CFC) of salbutamol sulfate, 288 mcg of ipratropium bromide)

    Study Document Trial synopsis 1012.24 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.25
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    A Randomized, Double-Blind, Crossover, Placebo- and Active-Controlled Dose-Confirmation Study of COMBIVENT HFA Inhalation Aerosol in Patients with COPD

    Study Document Trial synopsis 1012.25 english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.32
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase III
    Study Title

    Open Study on the Efficacy and Safety of CombiVent® Aerosol (120 mcg Salbutamol sulfate+ 20 mcg ipratropimm bromide)+ Spacer, 12 to24 puffs, in adult patients with moderate-to-severe asthma crisis

    Study Document Trial synopsis 1012.32_CO english
  • COMBIVENT ® - Asthma
    Clinical Study Number 1012.36
    Study Indication Asthma
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    COMBIVENT vs. SALBUTAMOL in patients with metacholine-induced bronchospasm.

    Study Document Trial synopsis 1012.36_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.39
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    A randomised, double-blind, active-controlled, within-patient trial comparing the effects of single doses of nebulised ipratropium 500 mcg, salbutamol sulphate 3mg, salbutamol sulphate 6mg, and the combination therapy salbutamol sulphate 3mg plus ipratropium 500 mcg (Combivent® UDVs®) on arterial oxygen saturation in patients with stable, moderate to severe chronic obstructive pulmonary disease.

    Study Document Trial synopsi 1012.39_CO english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.43
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IIb
    Study Title

    Safety assessment of cumulative doses of Combivent® HFA-propelled metered dose inhaler in comparison to Combivent ® CFC-propelled metered dose inhaler A randomised, double-blind, active-controlled, two-way cross-over study in COPD patients

    Study Document Trial synopsis 1012.43 english
  • COMBIVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 1012.65
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product COMBIVENT ®
    Generic Name Ipratropium bromide + Salbutamol
    Lab Code
    Clinical Phase IV
    Study Title

    Open label, non-randomised, 1-day trial to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler device with patients requiring mechanical ventilation

    Study Document Trial synopsis 1012.65 english

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