Postmarketing Surveillance Study of Anticholinergics – Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)

Overview

To obtain further information on the prescribing pattern and therapeutic long term value in patients suffering from moderate or severs 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 Anticholinergics – Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease”

Study Type

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

Interventions

  • Drug: Atrovent®
  • Drug: Ventilat®

Arms, Groups and Cohorts

  • Chronic Obstructive Pulmonary Disease
    • patients receiving Atrovent®
  • Cronic Obstructive Pulmonary Disease
    • patients receiving Ventilat®

Clinical Trial Outcome Measures

Primary Measures

  • Change in overall severity of the clinical picture rated on a 4-point scale
    • Time Frame: Up to 6 months after first study drug administration
  • Investigator assessment of improvement of thec linical picture rated on a 6-point symptom profile
    • Time Frame: Up to 6 months after first study drug administration

Secondary Measures

  • Assessment of efficacy by investigator on a 4-point scale
    • Time Frame: Up to 6 months after first study drug administration
  • Assessment of efficacy by patient on a 4-point scale
    • Time Frame: Up to 6 months after first study drug administration
  • Assessment of tolerability by investigator on a 4-point scale
    • Time Frame: Up to 6 months after first study drug administration
  • Assessment of tolerability by patient on a 4-point scale
    • Time Frame: Up to 6 months after first study drug administration
  • Number of patients with adverse drug reactions
    • Time Frame: Up to 6 months after first study drug administration

Participating in This Clinical Trial

Inclusion Criteria

  • Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease – Only patients who showed following diagnosis parameters were to be considered for inclusion – FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) <70% – Reversibility FEV1 <12% in the last 6 months – Smoker or Ex-smoker (>10 Pack years) – Asthma to be excluded Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics

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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