Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

Overview

The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Full Title of Study: “Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1999

Interventions

  • Drug: Berodual®

Arms, Groups and Cohorts

  • chronic obstructive respiratory tract disease patients

Clinical Trial Outcome Measures

Primary Measures

  • Overall severity of the clinical picture rated on a 4-point scale
    • Time Frame: after 3 and 6 weeks

Secondary Measures

  • Changes in dyspnea and/or asthma attacks rated on a 4-point scale
    • Time Frame: after 3 and 6 weeks
  • Number of dyspnea episodes rated on a 4-point scale
    • Time Frame: after 3 and 6 weeks
  • Number of awakenings due to night-time dyspnea rated on a 4-point scale
    • Time Frame: after 3 and 6 weeks
  • Assessment of morning coughing with expectoration on a 4-point scale
    • Time Frame: after 3 and 6 weeks
  • Assessment of tolerability on a 4-point scale
    • Time Frame: after 3 and 6 weeks
  • Number of patients with adverse drug reactions
    • Time Frame: up to 6 weeks
  • Changes in pathological auscultation findings rated on a 3-point scale
    • Time Frame: after 3 and 6 weeks
  • Changes in concomitant medication
    • Time Frame: up to 6 weeks
  • Assessment of efficacy on a 4-point scale
    • Time Frame: after 3 and 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with diagnosis of Chronic obstructive respiratory tract disease – Patients of either sex, including children over 6 years Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 6 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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