Post-marketing Surveillance of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease

Overview

Study to obtain further information on the tolerability and efficacy of Atrovent® inhalets in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Full Title of Study: “Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2002

Interventions

  • Drug: Atrovent® – inhalets

Arms, Groups and Cohorts

  • Chronic obstructive pulmonary disease patients

Clinical Trial Outcome Measures

Primary Measures

  • Change in overall severity of the clinical picture
    • Time Frame: 3 months

Secondary Measures

  • Assessment of efficacy by investigator on a 4-point scale
    • Time Frame: after 3 months
  • Assessment of efficacy by patient on a 4-point scale
    • Time Frame: after 3 months
  • Number of patients with adverse drug reactions
    • Time Frame: 3 months
  • Assessment of tolerability by investigator on a 4-point scale
    • Time Frame: after 3 months
  • Assessment of tolerability by patient on a 4-point scale
    • Time Frame: after 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease
  • Only patients who have not been treated with Atrovent® within the last year are to be considered for inclusion

Exclusion Criteria

  • Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® metered dose inhaler

Gender Eligibility: All

Minimum Age: 40 Years

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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