Value through Innovation27 July 2016

Clinical Study Results

  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2502
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2502_CO english
  • ATROVENT ® - Common Cold
    Clinical Study Number 244.2503
    Study Indication Common Cold
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IIIb/IV
    Study Title

    A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) with Rhinorrhea Associated with a Common Cold or Allergy

    Study Document Trial synopsis 244.2503_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2507
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IIIb
    Study Title

    ATROVENT HFA open-label Actuation Indicator evaluation and handling study in Adults with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2507_DS_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2496
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® in long-term therapy in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2496_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2500
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance study (as per § 67 (6) AMG [German Drug Law]) of Atrovent® 500 µg/2 ml inhalation solution in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2500_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2501
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (as per § 67 (6) AMG [German Drug Law]) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2501_CO english
  • ATROVENT ® - Asthma
    Clinical Study Number 244.2413
    Study Indication Asthma
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Double-blind, controlled trial to assess the efficacy of ipratropium bromide associated with high dose salbutamol by repeated nebulisation versus repeated nebulisation of salbutamol alone, for 120 minutes, in acute asthmatic attacks in young children.

    Study Document Trial synopsis 244.2413_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2480
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 mcg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 mcg ATROVENT® CFC  Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2480_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2484
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase III
    Study Title

    A six month, double-blind (within formulation), randomized, multiple dose trial to compare the safety and efficacy of 20 mcg and 40 mcg of ipratropium bromide, as delivered by the Respimat® device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 puffs) and respective placebos in adults, with chronic obstructive pulmonary disease

    Study Document Trial synopsis 244.2484 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2489
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Double-Blind, Placebo Controlled Trial to Assess the Safety of Two-Week Administration of 80 Mcg Q.I.D. and 160 Mcg Q.I.D. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients with Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2489_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2491
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document Trial synopsis 244.2491 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2492
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® Inhaletten® in chronic obstructive airways disease

    Study Document Trial synopsis 244.2492 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2493
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Postmarketing surveillance study (as per§ 67 (6) AMG [German Drug Law]) of Atrovent® unit dose vial 500 mvg in chronic obstructive airways disease

    Study Document Trial synopsis 244.2493 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2497
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of Atrovent® inhalets in Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2497 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2498
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase II
    Study Title

    A Single-Dose, Double Blind, Crossover Trial to Determine the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, ATROVENT® CFC Inhalation Aerosol, in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Study Document Trial synopsis 244.2498_CO english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2499
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Post-marketing surveillance (in accordance with § 67 (6) AMG) of anticholinergics -prescribing pattern and therapeutic long-term value in patients suffering from moderate or severe Chronic Obstructive Pulmonary Disease

    Study Document Trial synopsis 244.2499 english
  • ATROVENT ® - Pulmonary Disease, Chronic Obstructive
    Clinical Study Number 244.2514
    Study Indication Pulmonary Disease, Chronic Obstructive
    Product ATROVENT ®
    Generic Name Ipratropium bromide
    Lab Code
    Clinical Phase IV
    Study Title

    Peri-operative intervention with nebulized ipratropium bromide in Chinese patients with chronic obstructive pulmonary disease (COPD): a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial

    Study Document Trial synopsis 244.2514_DR english

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