Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Overview

Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Full Title of Study: “Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2004

Interventions

  • Drug: Berodual® Respimat® solution for inhalation

Arms, Groups and Cohorts

  • chronic obstructive airways disease patients

Clinical Trial Outcome Measures

Primary Measures

  • Change in overall severity rated on 3-point scale
    • Time Frame: up to 4 weeks
  • Change in reduction in breathlessness rated on a 4-point scale
    • Time Frame: up to 4 weeks
  • Change in restriction of activity due to breathlessness rated on a 4-point scale
    • Time Frame: up to 4 weeks
  • Number of awakening due to nocturnal breathlessness rated on 4-point scale
    • Time Frame: up to 4 weeks
  • Global assessment of efficacy by the patients rated on 5-point scale
    • Time Frame: after 4 weeks
  • Global assessment of efficacy by the investigator rated on 5-point scale
    • Time Frame: after 4 weeks
  • Number of patients with adverse drug reactions
    • Time Frame: up to 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Men and women presenting with symptoms of chronic obstructive pulmonary disease – Both previously untreated patients and patients treated previously with Berodual® or with other anti-obstructive respiratory tract agents may be included Exclusion Criteria:

  • Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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