Postmarketing Surveillance Study of Atrovent® Inhalation Solution in Chronic Obstructive Pulmonary Disease

Overview

To obtain further information on the tolerability and efficacy of Atrovent® 500µg/2ml inhalation solution in the treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Full Title of Study: “Postmarketing Surveillance Study (as Per §67 (6) AMG [German Drug Law]) of Atrovent® 500µg/2ml Inhalation Solution in Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2001

Interventions

  • Drug: Atrovent® Inhalation Solution

Arms, Groups and Cohorts

  • Chronic Obstructive Pulmonary Disease

Clinical Trial Outcome Measures

Primary Measures

  • Change in total severity of the clinical picture rated on a 4-point scale
    • Time Frame: Up to 4 weeks after first study drug administration
  • Investigator assessment of improvement of the clinical picture of the course on a 6-point symptoms profile
    • Time Frame: up to 4 weeks after first study drug administration

Secondary Measures

  • Assessment of efficacy by investigator on a 4-point scale
    • Time Frame: Up to 4 weeks after first study drug administration
  • Assessment of efficacy by patient on a 4-point scale
    • Time Frame: Up to 4 weeks after first study drug administration
  • Assessment of tolerability by investigator on a 4-point scale
    • Time Frame: Up to 4 weeks after first study drug administration
  • Assessment of tolerability by patient on a 4-point scale
    • Time Frame: Up to 4 weeks after first study drug administration
  • Number of patients with adverse drug reactions
    • Time Frame: Up to 4 weeks after first study drug administration

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 had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria

  • Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® 500µg/2ml Inhalation Solution
  • Patients who exhibited adverse drug reactions

Gender Eligibility: All

Minimum Age: 13 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

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